MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INSTALERT HCG STRIP(URINE) 50T; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-101

Device Problem False Negative Result (1225)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event: was entered as 1mar2024 as an event date was not provided.Results pending completion of the investigation.

Event Description

The customer reported receiving a false negative result when using the instalert hcg one step pregnancy test strip.No adverse event reported.Although requested, no further details were reported.

Event Description

New information received noted the customer reported receiving a false negative result when using the instalert hcg one step pregnancy test strip.The patient presented for routine testing "prior to scanning".A urine sample from the patient was used for testing where the dipstick was submerged in the urine for 20 seconds.The customer indicated a timer was used and the results were read at 3 minutes which resulted in a negative result.No confirmatory testing was performed; however, the customer indicated the result were also checked by two additional staff members.It is unclear if the "scanning" took place as the customer reported no negative impact.Although requested, no further information was provided.

Manufacturer Narrative

B3 - date of event: was changed from 1mar2024 to 1feb2024 as, although an event date was not provided, the customer indicated that the event occurred in february.B5 - describe event or problem was updated as new information was obtained.G4 - combination product was previously submitted as blank and was updated to "no".H6 - adverse event problem and h11 - additional mfg narrative fields were updated to include investigation findings.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 (261.6 iu/ml, 264.5 iu/ml, and 266.0 iu/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: - the hcg one step pregnancy test strip (urine) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hcg can be determined by this test.- 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.- 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 may produce false negative results.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.In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

• Brand Name: INSTALERT HCG STRIP(URINE) 50T
• 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: 19008692
• MDR Text Key: 339127205
• Report Number: 2027969-2024-00040
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00810124272579
• UDI-Public: (01)00810124272579(17)250824(10)0000774842
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Catalogue Number: FHC-101
• Device Lot Number: 0000774842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2023
• 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 Sex: Female