MAUDE Adverse Event Report: FISHER - SURE-VUE HCG SERUM/URINE (50T); HCG PREGNANCY TEST

Model Number FHC - 202

Device Problem False Negative Result (1225)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of false negative urine hcg on fisher - sure-vue hcg serum/urine (50t).On (b)(6) 2016 patient's urine home test result was negative.On (b)(6) 2016 patient came into facility and was tested by serum sample, lot hcg6020079, and result was negative.On (b)(6) 2016 patient returned to facility and was tested by serum sample, lot hcg6050071, and result was positive.Customer tested serum samples from both days for quant testing via beckman dxi (range is >5.0=pregnant).On (b)(6) 2016 sample yielded 0 miu/ml.On (b)(6) 2016 sample yielded 9,000 miu/ml.Patient's lmp not available.On (b)(6) 2016 pregnancy confirmed by ultrasound; patient was 16 weeks and 5 days into her pregnancy.No reported adverse patient sequela.

Manufacturer Narrative

Investigation conclusion: retention devices of the reported lot were tested with cutoff serum standard (25miu/ml hcg) and all devices produced positive results.All devices met the qc specification and no false negative results were observed.The customer's results were replicated with returned samples tested on retained devices; however, hcg quantitative analysis produced results in agreement with the in-house sample testing.Retained devices produced negative results with the (b)(6) 2016 sample (quantitative= 1.0 miu/ml hcg) and positive results with the (b)(6) 2016 sample (quantitative= >1,000 miu/ml hcg).All results met the qc specification.Quantitative hcg analysis of the samples revealed that the product performed as expected.No false negative results were observed during in-house testing and the product performed as expected.A review of manufacturing batch records did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Correction: device available for evaluation incorrectly selected as "yes" with a returned to manufacturer date of 12/06/2016.The corrected selected for this field is "no" with no returned to manufacturer date.Device evaluated by manufacturer incorrectly selected as "yes." the corrected selected for this field is "no" with "not returned to manufacturer" also selected.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE (50T)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6186183
• MDR Text Key: 63088393
• Report Number: 2027969-2016-00706
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• 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,Followup
• Report Date: 12/01/2016

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 - 202
• Device Lot Number: HCG6020079
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• 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