MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Type  malfunction  

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 results were not replicated in-house with returned and retention products of the reported lot.Returned and retention products were tested with clinical hcg-negative urine and all devices produced negative hcg results at the read time.All results met the qc specification.No false positive results were observed.Manufacturing batch record review did not uncover any abnormalities.It was reported that the customer interpreted results prior to the 3-5 minutes read time.Per the product insert - interpretation of results, "because of the high sensitivity of this test, results should be read between 3 and 5 minutes only".Although the customer interpreted results prior to read time, a root cause could not be determined.

Event Description

It was reported that a patient had an hcg test where a positive line developed before the read time, then by the read time the line had either disappeared or became very faint.The result was interpreted as a positive result and the patient was told that she was pregnant.When the patient went to the initial obgyn appointment, the confirmatory serum test was negative.The customer did not have the actual results.The patient had a delay in receiving an iud due to the false positive result.No further information available.Troubleshooting occurred with a discussion about storage and technique per the package insert.The importance of making sure the specimen was at room temperature, particulates should be allowed to settle and abiding by the read time of 3 minutes was explained.

• Brand Name: CONSULT HCG URINE CASSETTE 5001 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9114332
• MDR Text Key: 190781319
• Report Number: 2027969-2019-00371
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: FHC-A102
• Device Lot Number: HCG6110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1