MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER - SURE-VUE HCG SERUM/URINE; HCG PREGNANCY TEST

Model Number	4581435021
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: retention products for the reported lot number were tested with clinical negative hcg urine.All test devices produced expected negative results at the read time.No false positive results were observed during testing.Manufacturing batch record review did not uncover any abnormalities and quality control data met specifications.The reported complaint for false positive results was not replicated as retention products performed as expected.A root cause could not be determined based on the information provided.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
It was reported that on (b)(6) 2018 a female patient had an hcg urine test with two false positive results.There was no delay in treatment and no adverse event reported.Although requested no other information was received.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9127121
• Report Number: 2027969-2019-00507
• Device Sequence Number: 1748951
• Product Code: JHI
• UDI-Device Identifier: 00613647000564
• UDI-Public: (01)00613647000564(17)200131(10)HCG8010123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 01/31/2020
• Device Model Number: 4581435021
• Device Catalogue Number: 23900528
• Device Lot Number: HCG8010123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR