MAUDE Adverse Event Report: SURESTRIP HCG PREGNANCY STRIPS 50 DET; HCG PREGNANCY TEST

Model Number FHC-101

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention product.Retention products were tested with 25 miu/ml hcg cutoff urine control and 3 high level of hcg urine controls (205.3 iu/ml, 210.7 iu/ml and 216.8 iu/ml), all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined based on the information provided by customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

A customer in the (b)(6) reported potential false negative urine hcg result with surestrip hcg pregnancy strips twice on one patient.The patient had performed five pregnancy tests at home with positive results and then two done at the doctor's office with negative results.The original test was done during the week of (b)(6) (not sure which day) and the second one was performed on (b)(6).The patient was then sent for a scan which confirmed her pregnancy.(note: this mdr filing is due to the device being the same or similar as a device available in the us).

• Brand Name: SURESTRIP HCG PREGNANCY STRIPS 50 DET
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5848330
• MDR Text Key: 51347888
• Report Number: 2027969-2016-00554
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: FHC-101
• Device Lot Number: HCG5080194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• 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