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

Model Number	FHC-A202
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: an investigation was performed on retention devices from the reported lot number.Retention devices were tested with clinical hcg-negative serum samples and results were read at 5-6 minutes.All devices produced expected negative results.No false positive results were observed.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.Case details indicate the user believes the technician made a mistake in documenting the initial test result, however a clerical error could not be verified.Furthermore, it was reported that 4 drops of sample were added to the cassette when testing.Per the package insert, hold the pipette vertically and transfer 3 full drops of serum (approx.100 ul) to the specimen well of the test cassette, and then start the timer.Read the results at 5-6 minutes when testing a serum specimen.Improper testing technique cannot be ruled out as a root cause for the reported issue.
Event or Problem Description
(b)(6) 2020: a (b)(6) old female visited clinic for an ob related surgery.Patients serum was collected at 14:30 and tested on the consult diagnostics hcg serum/urine combo cassette at 16:05 and came back positive.(b)(6) 2020: confirmatory test performed using the same serum sample collected on (b)(6) 2020 provided a negative result of <0.10 miu/ml.Repeat testing was performed 2x with the same serum sample on tests from the same kit and provided the expected negative result both times.Although further information was requested regarding the type of surgery, no further information was able to be obtained.Customer states the surgery was not delayed.No adverse outcomes reported.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002 25
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca
• MDR Report Key: 9975384
• Report Number: 2027969-2020-00019
• Device Sequence Number: 19018164
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)210831(10)HCG9082044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• 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): 04/17/2020

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: 08/31/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9082044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 83