MAUDE Adverse Event Report: ALERE SAN DIEGO HCG ONE STEP PREGNANCY TEST DEVICE (URINE); HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention products from the reported lot number.Retention devices were tested with qc cut-off standard (25 miu/ml) and results were read at 3 minutes.All devices produced expected positive results.No false negative results were observed.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release 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.The reported complaint was not replicated.A probable cause could not be determined based on the information available.Per the package insert: the hcg one step pregnancy test device (urine) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hcg can be determined by this 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.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

A customer reported that when the hcg one step pregnancy test device (urine) was administered, a false negative result occurred.The patient had a positive home pregnancy test (date unknown) and a positive confirmatory blood test ((b)(6) 2020) quant 4901 iu/l.There was no delay in treatment nor was any treatment withheld or given due to the false negative result.

Manufacturer Narrative

B3: event date (b)(6) 2020 b5: the customer reported that when the hcg one step pregnancy test device (urine) was administered on (b)(6) 2020, a false negative result occurred.The patient had a positive home pregnancy test (date unknown) and a positive confirmatory blood test (07/14/20) quant 4901 iu/l.There was no delay in treamtnent nor was any treatment withheld or given due to the false negative result.B6: (b)(6) 2020 hcg one step pregnancy test device (urine) false negative result.D9: selected "yes" for product return.

Event Description

The customer reported that when the hcg one step pregnancy test device (urine) was administered on (b)(6) 2020, a false negative result occurred.The urine was not a first morning sample and taken at an unknown time of day.The patient had a positive home pregnancy test (date unknown) and a positive confirmatory blood test (07/14/20) quant 4901 iu/l.There was no delay in treatment nor was any treatment withheld or given due to the false negative result.

Manufacturer Narrative

D8: was this device serviced by a 3rd party, no.D9: returned to manufacturer 11/19/2020.H3: device evaluated by manufacturer: yes.Investigation conclusion: an investigation was performed on retention and returned products from the reported lot number.All devices were tested with qc cut-off standard (25 miu/ml) and middle positive sample (100 miu/ml).Results were read at 3 minutes.All devices produced expected positive results.No false negative results were observed.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release 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.The reported complaint was not replicated.A probable cause could not be determined based on the information available.Per the package insert: the hcg one step pregnancy test device (urine) is a preliminary qualitative test, therefore, neither the quantitative value nor the rate of increase in hcg can be determined by this 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.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: HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego, ca
• MDR Report Key: 10479426
• MDR Text Key: 219179571
• Report Number: 2027969-2020-00050
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: FHC-102
• Device Lot Number: HCG9102057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR