MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URIN/SRM COMBO 5002 25; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the patient did not provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2017, the patient went to the facility to confirm a pregnancy after received a positive result on an over-the-counter pregnancy test.A urine sample was collected and the consult hcg urine/serum combo test produced a negative result.On an unspecified date, the patient was tested again using the consult hcg urine/serum combo test and received a positive hcg result.Several weeks later, an ultrasound was performed and did not confirm a pregnancy.Another urine sample was collected and the consult hcg urine/serum combo test produced a negative result.Although requested, no additional information was provided.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002 25
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 7073517
• MDR Text Key: 93828533
• Report Number: 2027969-2017-00177
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• 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