MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER SURE-VUE HCG STAT SERUM/URINE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A202B

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

H6 - adverse event problem: health effect - impact code- "f28 appropriate term/code not available", selected to capture the medical procedure the patient underwent as a result of the false negative hcg result.The procedure may not have been carried out if the patient had been known to be pregnant.Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with cut-off standards (20 miu/ml) and high positive standards (200.77iu/ml, 204.78iu/ml, and 270.50iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negatives 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 relevant non-conformances 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 serum or 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.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.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 Description

The customer reported receiving a false negative result while using the fisher sure-vue hcg stat serum/urine test.The patient presented prior to undergoing a colonoscopy.A fresh urine sample was provided by the patient that was non-cloudy and dark yellow in appearance.The results were read at 4 minutes and a negative hcg result was observed.The patient then underwent the procedure that required anesthesia.As the customer went to discard the test after the read window, the customer reported the device then showed a positive result.As a result, two additional hcg test were performed: one test was performed using the same urine sample and a second test was performed using the patient's serum.The customer reported both additional tests yielded positive hcg results.No adverse event was reported.The patient was scheduled to follow up with their obgyn.No further information was provided.

Event Description

The customer reported receiving a false negative result while using the fisher sure-vue hcg stat serum/urine test.The patient presented prior to undergoing a colonoscopy.A fresh urine sample was provided by the patient that was non-cloudy and dark yellow in appearance.The results were read at 4 minutes and a negative hcg result was observed.The patient then underwent the procedure that required anesthesia.As the customer went to discard the test after the read window, the customer reported the device then showed a positive result.As a result, two additional hcg test were performed: one test was performed using the same urine sample and a second test was performed using the patient's serum.The customer reported both additional tests yielded positive hcg results.No adverse event was reported.The patient was scheduled to follow up with their obgyn.No further information was provided.

Manufacturer Narrative

Device available for evaluation: previously submitted as "yes" and has been updated to "no" as a return was not received.H3 - reason device not evaluated by mfg and h3 - additional text: were not updated as a return was not received.Adverse event problem: health effect - impact code- "f28 appropriate term/code not available", selected to capture the medical procedure the patient underwent as a result of the false negative hcg result.The procedure may not have been carried out if the patient had been known to be pregnant.Investigation conclusion: an investigation was performed on retention product from the reported lot number.Retention devices were tested with cut-off standards (20 miu/ml) and high positive standards (200.77iu/ml, 204.78iu/ml, and 270.50iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negatives 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 relevant non-conformances 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 serum or 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.- as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.- 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.Although request, returned product was not received.

• Brand Name: FISHER SURE-VUE HCG STAT SERUM/URINE
• Type of Device: 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: 18447483
• MDR Text Key: 332151024
• Report Number: 2027969-2024-00001
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Model Number: FHC-A202B
• Device Catalogue Number: 23900531
• Device Lot Number: 0000680739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female