MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER - SURE-VUE HCG SERUM/URINE (50T); HCG PREGNANCY TEST

Model Number	FHC-202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
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 devices for the reported lot were tested with clinical negative urine samples.Results read at 3 minutes all produced expected negative results.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention products performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.Case details note that 4 drops of urine sample were applied to the device.Per the package insert only 3 drops should be applied.This cannot be ruled out as a possible root cause for the reported issue.
Event or Problem Description
Customer called to report unconfirmed false positive hcg urine result x1 on sure-vue serum/urine hcg.It was reported by the customer that an unconfirmed false positive hcg urine result occurred on (b)(6) 2018.A female patient was tested as a screening procedure used by a study conducted by the (b)(6).In order to be eligible for the study, the patients cannot be pregnant as they will undergo an elective mri procedure.The patient sample was tested two times resulting in one positive result followed by a negative result.The customer confirmed that not being eligible for the study did not affect the patient health, no adverse outcomes experienced.Troubleshooting occurred with a discussion about the false positive test results and possible causes including technique storage and handling.
Additional Manufacturer Narrative
Correction to b4: initial mdr did not have the "date of this report" field populated.Correct date of the initial report: 09/27/2019.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE (50T)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9127116
• Report Number: 2027969-2019-00505
• Device Sequence Number: 2529290
• Product Code: JHI
• UDI-Device Identifier: 00613647000540
• UDI-Public: (01)00613647000540(17)190531(10)HCG7050200
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: FHC-202
• Device Catalogue Number: 23900529
• Device Lot Number: HCG7050200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1