MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG CASSETTE; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

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

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Caller reported potential false negative urine hcg results on consult diagnostics hcg cassette.Serum quant was positive but the customer cannot provide the concentration.The serum quant was used as the confirmatory method of confirming patient's pregnancy.No further details are available.

Manufacturer Narrative

Investigation pending.

• Brand Name: CONSULT DIAGNOSTICS HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• 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: 3831966
• MDR Text Key: 4451386
• Report Number: 2027969-2014-00187
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• 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: 02/18/2014

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-A102-OBC554
• Device Lot Number: HCG2080144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/06/2014
• 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
• Patient Age: 18 YR