MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URINE CASSETTE 5001- 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention and return products.Retention (n=29) and return devices were tested in-house clinical hcg negative urine samples, all results were negative at 3 minutes read time.No false positives were obtained.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided and without patient specimen in-house analysis.

Event Description

It was reported that on (b)(6) 2015, the patient presented to the facility and had 2 positive pregnancy results.The patient's urine was tested with consult hcg urine cassette.A sample was sent to the lab for confirmatory testing and produced a serum beta quant of <5miu/ml.The patient then returned to the lab on the same day and a positive result occurred twice again.No further information was provided.Troubleshooting was conducted with the customer.The customer was advised on possible causes of false positives on urine hcg including technique and handling.

• Brand Name: CONSULT HCG URINE CASSETTE 5001- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9130540
• MDR Text Key: 189710670
• Report Number: 2027969-2019-00099
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: FHC-A102
• Device Lot Number: HCG4040103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2015
• 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: N
• Patient Sequence Number: 1