MAUDE Adverse Event Report: UNSPECIFIED LATERAL FLOW HCG TEST; HCG PREGNANCY TEST

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion further investigation cannot be pursued as no model number or lot number was provided.

Event Description

Report received multiple false negative results for multiple patients using an unspecified lateral flow hcg test.Caller indicated ultra sound or blood draw was used to confirm pregnancies.Customer did not have the lot or brand name information.No patient information provided.No reported adverse patient sequela.

• Brand Name: UNSPECIFIED LATERAL FLOW HCG TEST
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6177336
• MDR Text Key: 62468773
• Report Number: 2027969-2016-00702
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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