MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG URINE CASSETTE; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's observation was not replicated in-house with retention and return products.Retention and return products were tested with qc cutoff hcg concentrations and high positive hcg urine standards.All devices showed positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The serum quant was reported as 25 miu/ml.A dilute urine sample may make the hcg quant level much less than the serum levels which may lead to false results.Some patients may test negative early in pregnancy if the urine hcg is below the cut-off of 25 miu/ml.It is recommended that if pregnancy is suspected, a first morning urine specimen should be collected 48 hours later and tested.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

A urine sample was collected from the patient was tested using a medline hcg urine cassette.The medline hcg urine cassette produced a negative hcg result.The patient then when to her physician's office where a blood sample was collected and produced a quantitative hcg result of 25 miu/ml.

• Brand Name: MEDLINE HCG URINE CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 7021575
• MDR Text Key: 92761806
• Report Number: 2027969-2017-00167
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)181031(10)HCG6110130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: FHC-102
• Device Lot Number: HCG6110130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• 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