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 a nexplanon implant placed in her arm for birth control.The patient returned to the physician's office about a week later after she had started spotting.Another pregnancy test was performed in the office and it came back with a positive result.The nexplanon implant had to be removed from the patient's arm.Per the physician, this caused an additional in office procedure for the patient and extra scarring.The patient was about four weeks pregnant based on her last menstrual period (lmp).The doctor stated that the patient is ok now and still pregnant with no complications thus far.No further treatment other than regular ob/gyn check-ups required and no hospitalization was necessary due to this incident.

• 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: 5199384
• MDR Text Key: 30322415
• Report Number: 2027969-2015-00894
• 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
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/03/2015
• 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