MAUDE Adverse Event Report: HCG ONE STEP PREGNANCY TEST STRIP (URINE); HCG PREGNANCY TEST

Model Number FHC-101B/2.5-ICBC01

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Additionally, the distributor was unable to provide a lot number for the device.Therefore, a review of the manufacturing records and testing on reserve sample from the same lot could not be performed.Further investigation cannot be pursued.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The distributor reported a false (b)(6) hcg result on a patient using the hcg one step pregnancy test strip (urine).The pregnancy was confirmed by a serum hcg test: 126 miu/ml.Timing between tests is unavailable.No additional information is available.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5982201
• MDR Text Key: 55788902
• Report Number: 2027969-2016-00632
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101B/2.5-ICBC01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• 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