MAUDE Adverse Event Report: ALERE SAN DIEGO UNSPECIFIED LATERAL FLOW HCG TEST; HCG PREGNANCY TEST

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 06/18/2011

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: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not provide a lot number.The root cause cannot be determined due to insufficient information.No corrective action is required.

Event Description

It was reported that a patient presented to the er on (b)(6) 2011 with unknown symptoms and was administered an hcg lateral flow test with a positive result.This was documented in a log book.This was compared to two negative results administered on (b)(6) 2011 and the second on (b)(6) 2011.No further information was provided.

• Brand Name: UNSPECIFIED LATERAL FLOW HCG TEST
• 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: 9130554
• MDR Text Key: 190004280
• Report Number: 2027969-2019-00532
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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