MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST DRIVE; HCG/PREGNANCY

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

Customer tested patient and received a false negative hcg result.Re-tested patient with the same sample with other three strips belonging to the same lot and received a positive result in all three cases.The sample has been confirmed as positive by quantitative lab method.Quantitative lab method; the value was 450 mu/ml.The false result was not reported to the patient.No patient information received.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Customer's observation was not replicated with in-house retain testing.The retain product of lot generated correct positive results with 25 miu/ml hcg urine control and three lots of high concentration hcg control.Root cause couldn't be determined at this time.Manufacturing document review didn't find any defect.Retain product of lot performed as expected.This issue will be tracked and trended.As there is no indication of a product deficiency, no corrective action is required at this time.

• Brand Name: HCG ONE STEP PREGNANCY TEST DRIVE
• Type of Device: HCG/PREGNANCY
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4109103
• MDR Text Key: 4700571
• Report Number: 2027969-2014-00825
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2014

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 Model Number: FHC-102
• Device Lot Number: HCG4020086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1