MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG DEVICE SP BRAND RAPID TEST; HCG PREGNANCY TEST

Model Number FHC-102-OBW515

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

Caller alleging one false negative urine hcg using cardinal urine cassette on (b)(6) 2014.Quantitative serum hcg result: 50 miu/ml performed same day.Sample discarded, unable to submit for investigation.No report adverse patient sequela.No additional information provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: HCG DEVICE SP BRAND RAPID TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4321849
• MDR Text Key: 18926828
• Report Number: 2027969-2014-01050
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102-OBW515
• Device Lot Number: HCG4040100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• 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