MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported receiving two false negative hcg results for one patient.The customer indicated the patient first presented on (b)(6) 2024 for an epidural steroid injection due to neck pain.Prior to the procedure, a henry schein one step+ hcg combo test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.The patient then presented on (b)(6) 2024 for an additional epidural steroid injection.Prior to the procedure, a henry schein one step+ hcg urine cassette test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.No adverse events were reported, however the patient did receive two steroid injections for pain management after receiving negative hcg results.On (b)(6) 2024, the patient presented to the emergency room after fainting.The cause of the fainting was not reported, however a pregnancy test was performed at the facility which noted the patient was 5 weeks pregnant.Although requested, no further information was provided.See mdr 2027969-2024-00044 for the event which took place on 10feb2024.
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported receiving two false negative hcg results for one patient.The customer indicated the patient first presented on (b)(6) 2024 for an epidural steroid injection due to neck pain.Prior to the procedure, a henry schein one step+ hcg combo test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.The patient then presented on (b)(6) 2024 for an additional epidural steroid injection.Prior to the procedure, a henry schein one step+ hcg urine cassette test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.No adverse events were reported, however the patient did receive two steroid injections for pain management after receiving negative hcg results.On (b)(6) 2024, the patient presented to the emergency room after fainting.The cause of the fainting was not reported, however a pregnancy test was performed at the facility which noted the patient was 5 weeks pregnant.Although requested, no further information was provided.See mdr 2027969-2024-00044 for the event which took place on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with cut-off standards (25 miu/ml) and high positive standards (261.6iu/ml, 264.5iu/ml, and 266.0iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: - very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.- this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Event or Problem Description
The customer reported receiving two false negative hcg results for one patient.The customer indicated the patient first presented on (b)(6) 2024 for an epidural steroid injection due to neck pain.Prior to the procedure, a henry schein one step+ hcg combo test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.The patient then presented on (b)(6) 2024 for an additional epidural steroid injection.Prior to the procedure, a henry schein one step+ hcg urine cassette test was selected and used to test for pregnancy.The customer indicated a negative hcg result was obtained and the patient was administered the epidural steroid injection.No adverse events were reported; however, the patient did receive two steroid injections for pain management after receiving negative hcg results.On (b)(6) 2024, the patient presented to the emergency room after fainting.The cause of the fainting was not reported; however, a pregnancy test was performed at the facility which noted the patient was 5 weeks pregnant.Although requested, no further information was provided.See mdr 2027969-2024-00044 for the event which took place on (b)(6) 2024.
Additional Manufacturer Narrative
D9 - device available for evaluation: updated from "no" to "yes" d9 - date returned to mfg: updated from blank to 2may2024 d9 - date returned to mfg null: updated from "na" to blank.H3 - device evaluated by mfg? updated from "no" to "yes".Investigation conclusion: an investigation was performed on retention and returned products from the reported lot number.Retention devices were tested with cut-off standards (25 miu/ml) and high positive standards (261.6iu/ml, 264.5iu/ml, and 266.0iu/ml).Returned devices were tested with cut-off standards (25 miu/ml) and high positive standards (203iu/m).All results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention and returned products.Complaints are tracked and trended on a monthly basis.Per the package insert: - very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.- this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.- this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE
• Common Device Name: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 19047932
• Report Number: 2027969-2024-00045
• Device Sequence Number: 8548457
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)250223(10)0000692274
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2025
• Device Model Number: FHC-102
• Device Catalogue Number: 9004073
• Device Lot Number: 0000692274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 08/09/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/18/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female