MAUDE Adverse Event Report: ALERE SAN DIEGO, INC SURESTEP HCG URINE CASSETTE; PREGNANCY TEST

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Pending results of investigation.Device return not requested; customer to monitor.

Event Description

Unspecified date: confirmed false positive result 1x on the surestep hcg urine kit.Confirmatory lab test determined patient was not pregnant.(type of confirmatory method was not specified).No treatment was withheld or any medical procedure performed based on the false positive result obtained.No additional information able to be provided.

Manufacturer Narrative

H6: patient code updated to 2199.Investigation conclusion: an investigation was performed on retention devices for the reported lot number.Retention devices were tested with clinical negative urine sample.Results were read at 3 and 4 minutes and all test devices produced expected negative results.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any abnormalities.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.The customer initially reported obtaining a confirmed false positive hcg result.Upon query for additional information, the customer stated that the issue had been resolved and the user was at fault.The customer stated that the user had read the results prior to the 4 minute read time window.No further information in regards to technique was provided.Per the package insert: - read the result at 3-4 minutes when testing a urine specimen.- do not interpret results after the appropriate read time.- it is important that the background is clear before the result is read.

• Brand Name: SURESTEP HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 9169955
• MDR Text Key: 189705123
• Report Number: 2027969-2019-00568
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: FHC-102
• Device Lot Number: HCG9010066
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1