MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD CONSULT DIAGNOSTICS HCG DIPSTICK; HCG PREGNANCY TEST

Model Number FHC-101-OBC517

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Ectopic Pregnancy (1819)

Event Date 06/24/2015

Event Type  Injury  

Manufacturer Narrative

The customer's results were not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml cutoff hcg urine control and 3 high level of hcg urine controls (205.2 iu/ml, 208.6 iu/ml, and 216.8 iu/ml); all results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any deviations or non-conformances.The root cause of the customer's false negative results could not be determined from the provided information 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

Caller reported a potential false negative urine hcg result with consult diagnostics hcg dipstick.After receiving the negative test result in the office, they placed an iud device in the patient for birth control.The patient left the office and a few weeks later she ended up in the hospital.The patient had a tubal pregnancy and needed surgery.She was 8 weeks pregnant at the time of the ectopic pregnancy surgery.The iud device was placed in the patient about 6 weeks before that, so she was about 2 weeks pregnant at the time of the iud placement.

• Brand Name: CONSULT DIAGNOSTICS HCG DIPSTICK
• 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: 5022785
• MDR Text Key: 23811680
• Report Number: 2027969-2015-00613
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: FHC-101-OBC517
• Device Lot Number: HCG4070214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• 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