MAUDE Adverse Event Report: CONSULT HCG URINE CASSETTE 5001-25T; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

Patient Problem Abdominal Pain (1685)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's observation was not replicated in-house with retention and return devices.Retention devices were tested with 20 mlu/ml hcg urine cutoff control and 3 high level of hcg urine controls (201.8 iu/ml and 205.2 iu/ml), all results were positive at 3 min read time.Returned devices were tested 20 mlu/ml cutoff hcg urine control and hcg high level 201.8 mlu/ml urine control; all results were positive at 3 min read time and met qc spec.No false negatives were obtained.Mfg batch record review did not uncover any abnormalities.Per pl, "false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested," root cause could not be determined without pt specimen in-house analysis.Based on the info available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Report received of a false negative hcg x 2 for one pt.Pt presented with abdominal pain.Pt's last menstrual period two months ago.Customer reported one pt's urine, collected 10am on (b)(6) 2015; rang negative at 3 minutes but at 30 minutes had a test line.Repeat run; negative at 3 minutes, test line at approx 13 minutes.No confirmatory results obtained.No specific pt info provided.No adverse pt sequela reported.No add'l details reported.

• Brand Name: CONSULT HCG URINE CASSETTE 5001-25T
• Type of Device: HCG PREGNANCY TEST

Manufacturer (Section D)

• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5252875
• MDR Text Key: 32289582
• Report Number: 2027969-2015-00954
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

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-A102-OBC554
• Device Lot Number: HCG5010146
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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