MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD INNOVACON HCG URINE TEST; HCG PREGNANCY TEST

Model Number IVFHC-102-ICBC01

Device Problem False Negative Result (1225)

Patient Problems Ectopic Pregnancy (1819); Complaint, Ill-Defined (2331)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

Customer reported potential false negative urine hcg results with innovacon hcg urine test.It was reported that a doctor was very unhappy when three female patients had negative results on the innovacon hcg test and their blood tests gave positive results (no actual result/values were provided).One of the three was an ectopic pregnancy.Although requested, no further information has been provided.

Manufacturer Narrative

Customer did not provide lot number and no product was returned for investigation.Further investigation cannot be pursued without this information.

• Brand Name: INNOVACON HCG URINE TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD; #198 12th street east; hangzhou, zhejiang zhejiang 31001 8; CH 310018
• Manufacturer (Section G): ABON BIOPHARM (HANGZHOU) CO., LTD; #198 12th street east; hangzhou, zhejiang zhejiang 3100 18; CH 310018
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4779165
• MDR Text Key: 21793959
• Report Number: 2027969-2015-00357
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IVFHC-102-ICBC01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• 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