MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URIN/SRM COMBO 5002 25; HCG PREGNANCY TEST

Model Number	FHC-A202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending investigation conclusion.
Event or Problem Description
It was reported that multiple false negative hcg results occurred in the same office when using the hcg urine cassette.Although requested, no information was provided about the events, or whether treatment was given or withheld.
Additional Manufacturer Narrative
Additional information: (b)(6).Investigation conclusion: an investigation was performed on retained products from the reported lot number.Retained devices were tested with qc cut-off standard (20 miu/ml) and high hcg-positive clinical urine (209.16-228.15 iu/ml).Results were read at 3 minutes and all devices produced 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.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 issue was not replicated as retained product performed as expected.A root cause could not be determined based on the information available.As stated in the product insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.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 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: CONSULT HCG URIN/SRM COMBO 5002 25
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9050815
• Report Number: 2027969-2019-00376
• Device Sequence Number: 11308118
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)201130(10)HCG8120028
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8120028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1