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

Model Number FHC-101-OBC517

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 06/24/2015

Event Type  malfunction  

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 potentially false negative urine hcg result with consult diagnostics hcg dipstick vs.Positive result with blood test.A female patient had a positive result on a home pregnancy test but a negative result when tested with the consult diagnostics hcg dipstick.Blood work was done on the same day that the false negative pregnancy test result was received because of the positive home pregnancy result.The blood work confirmed that the patient was pregnant.

• 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: 5022705
• MDR Text Key: 24816079
• Report Number: 2027969-2015-00612
• 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?: No
• 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