MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD CONSULT HCG URIN/SRM COMBO 5002- 25T; HCG PREGNANCY TEST

Model Number FHC-A202-OBC554

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Misdiagnosis (2159)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls; all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing 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.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

Event Description

Customer reported potential false negative urine hcg result with consult hcg urine/serum combo test.After receiving the negative result, the female patient had an intrauterine device (iud) inserted.A medical assistant, concerned with the reliability of the test, repeated the pregnancy test in an hour which produced a positive result.Patient did home test and test at another medical facility and both were positive.No blood quantitative testing available.No known further treatment and no hospitalization was necessary due to this incident.

Manufacturer Narrative

Corrections to the original medwatch report concerning the type of report: the report type was checked as an adverse event but should have only been checked as a malfunction.This section should not have had any checks since this was not an adverse event in the original medwatch report, it was reported that after receiving negative urine hcg results, the female patient had an iud inserted.It was later learned that this procedure had been planned but later cancelled after the follow up results were positive.The type of reportable event should be malfunction - not serious injury as checked on the initial medwatch report (b)(4).

Event Description

In the original medwatch report, it was reported that after receiving negative results, the female patient had an iud inserted.It was later discovered that this procedure had been planned but cancelled after the follow-up results were positive.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002- 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD; #198 12th street east; hangzhou econ & tech dev area; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer (Section G): ABON BIOPHARM (HANGZHOU) CO., LTD; #198 12th street east; hangzhou econ & tech dev area; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5199530
• MDR Text Key: 30322233
• Report Number: 2027969-2015-00895
• 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: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: FHC-A202-OBC554
• Device Lot Number: HCG4080154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• 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
• Patient Outcome(s): Other