MAUDE Adverse Event Report: ALERE SAN DIEGO SURE-VUE HCG TEST; HCG PREGNANCY TEST

Model Number	FHC-202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/20/2017
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: the customer's observation was not replicated in-house with retention products.Retention devices were tested with an in-house clinical hcg negative urine sample as well as a low level hcg urine standard.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided.
Event or Problem Description
It was reported by a lab director that a patient came into the clinic for contraceptives and a false positive result occurred with the hcg serum/urine test.The patient tested positive on hcg test but the serum quant came back at <2miu/ml.The patient was instructed to come back in a few weeks.A second rapid test also came back as a false positive.No patient outcome provided; unknown if patient received contraceptive treatment.Trouble shooting occurred with a review of storage, technique, and handling - no deviations noted.Tss discussed using only clear urine specimens free of particulates, variance of hcg clearance rates in individuals post pregnancy, and possibility of hama interference.

• Brand Name: SURE-VUE HCG TEST
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9114391
• Report Number: 2027969-2019-00444
• Device Sequence Number: 2383417
• Product Code: JHI
• UDI-Device Identifier: 00613647000540
• UDI-Public: (01)00613647000540(17)190131(10)HCG7010129
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 01/31/2019
• Device Model Number: FHC-202
• Device Catalogue Number: 23900529
• Device Lot Number: HCG7010129
• 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: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR