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

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/10/2017
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 in-house clinical negative hcg urine samples.All hcg results were negative at read time and met qc specification.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The customer stated 3-4 drops of sample are used during testing and results are interpreted at 5 minutes.According to the pi, 3 full drops of sample should be used and test results should be read between 3-4 minutes.Because return products or specimen were not available, further investigation was not pursued.A root cause could not be determined based on the information provided.
Event or Problem Description
It was reported that a patient presented for an iud insertion at the family health center.A rapid assay yielded a positive urine hcg result which was questioned by the patient who was 8 weeks post-partum.A second urine was collected which was also positive on rapid assay.Bloodwork was then ordered, same day ((b)(6)2017) which resulted as zero hcg.The serum was not run on the rapid assay.No negative impact occurred due to the false positive result, no adverse events.Troubleshooting occurred with a discussion about storage/handling/technique, sources of false positive results with focus on 3 drops of sample, not 3-4 drops; and read time of 3-4 minutes, not 5 minutes.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9114399
• Report Number: 2027969-2019-00452
• Device Sequence Number: 11673295
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)190228(10)HCG7030080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• 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: 02/28/2019
• Device Model Number: FHC-A202
• Device Lot Number: HCG7030080
• 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: 24 YR