MAUDE Adverse Event Report: ALERE SAN DIEGO MEDLINE HCG URINE DIPSTICK; HCG PREGNANCY TEST

Model Number FHC-101

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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 observation was not replicated in-house with retention products of the reported lot.Retention products were tested with qc cut-off hcg urine standards and clinically negative urine samples.All devices tested with qc cutoff standards showed positive results at read time meeting qc specifications.Additionally, devices tested with clinically negative urine samples showed expected negative results at read time.No false results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined based on the information provided.

Event Description

It was reported that the distributor emailed they had 3 faulty test readings before they had a correct one the other day and now with the 2nd box they are having false readings as well.No further information available.

• Brand Name: MEDLINE HCG URINE DIPSTICK
• 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: 9114380
• MDR Text Key: 192485910
• Report Number: 2027969-2019-00438
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191877
• UDI-Public: (01)30884389191877(17)181130(10)HCG6120176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• 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: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Lot Number: HCG6120176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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