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

Model Number FHC-A202

Device Problem False Positive Result (1227)

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

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention and return products.Retention and return devices were tested with in-house clinical hcg negative urine samples as well as low concentration hcg standards.All hcg results were negative at read time.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported the following events occurring for one patient: on (b)(6) 2017, the patient was tested prior to a scheduled essure permanent sterilization procedure.A urine sample was collected and tested using four consult hcg urine/serum combo tests from two different boxes of the same lot.Each consult hcg urine/serum combo test produced a positive result.The procedure was cancelled and a serum sample was drawn and sent out for testing.The serum beta quantitative test produced a negative hcg result of <2 miu/ml.After receiving the laboratory result, the essure permanent sterilization procedure was rescheduled.The customer reported that this procedure was elective.These events are being conservatively reported as the medical procedure was cancelled.

• 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: 6719750
• MDR Text Key: 80248331
• Report Number: 2027969-2017-00115
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)180731(10)HCG6090154
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Lot Number: HCG6090154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 39 YR