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

Model Number FHC-A202-OBC554

Device Problem False Negative Result (1225)

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

Event Date 01/31/2014

Event Type  malfunction  

Event Description

Caller alleged false negative hcg results.Results as follows: complaint was received on (b)(6) 2014 in a batch report from the distributor.Doctor does not feel comfortable using this lot number.Lot number was not provided.It is unknown if confirmatory testing was performed.

Manufacturer Narrative

Customer did not provide a lot number.Unable to perform retain product testing.No further investigation is possible due to insufficient event details.Unable to determine root cause from the information provided.A review of complaints against this product and trend code for february 2014 indicate that product performance has not exceeded the upper control limit for further action.This issue will be subject to tracking and trending.Corrective action is not required at this time.

• Brand Name: CONSULT DIAGNOSTICS HCG COMBO 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: 3831923
• MDR Text Key: 4399456
• Report Number: 2027969-2014-00192
• 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,Distributor
• 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-A202-OBC554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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