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

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

Patient Problem Miscarriage (1962)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Email received from distributor alleging false negative urine hcg.Patient took a pregnancy test at home with a positive result and received a false negative in the office.Patient had a miscarriage after the office visit and called back to advise the doctor of the incident.Patient did not require surgery or any hospitalization due to this incident.Although requested, no additional information provided.

Manufacturer Narrative

Investigation conclusion update: customer's observation was not replicated in-house with retention and return devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls (203.4 iu/ml, 208.6 iu/ml and 216.8 iu/ml), all results were hcg positive at read time.No false negatives were obtained.Return products were tested with hcg 20 miu/ml cutoff urine control and high level 201.8 iu/ml hcg urine control, all results were positive, no false results were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: CONSULT HCG URINE CASSETTE 5001- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ABON BIOPHARM (HANGOU) CO. LTD.; #198 12th street east; hangzhou economic & technologi; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5112327
• MDR Text Key: 27107795
• Report Number: 2027969-2015-00817
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• 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: HCG4060149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• 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: Unknown
• Patient Sequence Number: 1