MAUDE Adverse Event Report: HENRY SCHEIN HCG DIPSTICK 25T (URINE); HCG PREGNANCY TEST

Model Number FHC-101-KHS25

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with 25 miu/ml hcg cutoff urine control, 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.The root cause could not be determined based on the information provided by the customer and without patient specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Report received of false negative urine hcg results.Patient's last menstrual period 05/21/2016.On 06/21/2016 per dr, they received two false negative results on one patient using henry schein hcg dipstick 25t (urine).Reportedly, previously the patient had two home pregnancy tests (brands not provided) on (b)(6) 2016 all with positive results.Patient also conducted four home pregnancy tests on (b)(6) 2016 after the office visit and again received positive results.All six home pregnancy tests yielded positive results.It was reported a blood test was performed and results were positive.No confirmatory results reported.No reported adverse patient sequela.

• Brand Name: HENRY SCHEIN HCG DIPSTICK 25T (URINE)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5815792
• MDR Text Key: 50408475
• Report Number: 2027969-2016-00532
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2016

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 Model Number: FHC-101-KHS25
• Device Lot Number: HCG4120088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/22/2016
• 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