MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD. PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Lot Number 10075682

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

Caller called to report that she took a pregnancy test prior to her gyn iud placement appt that gave her a positive result.Once she got to her dr's office, a pregnancy blood test was administered and that result was negative.Reporter states she found two hundred and thirty complaints about the equate / (b)(6) brand giving false positive pregnancy test results.

• Brand Name: PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD.
• MDR Report Key: 9134699
• MDR Text Key: 160668189
• Report Number: MW5090095
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Lot Number: 10075682
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 MO