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 Code Available (3191)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retention product for the reported lot was tested with quality control cut-off standard (25miu/ml hcg urine).Results were read at 3 minutes and all devices showed expected positive results.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention products performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.Per the package insert, very dilute urine may not contain representative levels of hcg.Additionally, results should be read at 3-4 minutes.Do not interpret results after the appropriate read time.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The event was initially reported by the distributor.On (b)(6) 2018, the patient presented to the facility at 1:00pm for an iud insertion.A non-first morning urine sample was collected and a medline hcg urine cassette produced a negative hcg result after 2-2.5 minutes (no timer used).The iud was subsequently inserted based on the negative hcg result.Approximately 15-20 minutes later, the customer observed that a positive result had developed on the medline hcg urine cassette.Bloodwork was immediately drawn and produced a serum quantitative hcg result of 31 miu/ml.On (b)(6) 2018, a repeat serum quantitative hcg test was performed and produced a result of 92 miu/ml.The iud removal was scheduled for (b)(6) 2018.Per the customer, the iud was removed and the patient still pregnant.Troubleshooting was conducted with the customer.The customer was determined to be interpreting the result prior to the appropriate read time and not using a timer.The customer was advised to interpret the result at 3-4 minutes and to use a timer.A sample hcg concentration below the cut-off of this test might result in a weak line appearing in the test region after an extended period of time.A line in the test region seen after the read time could be indicative of a low hcg level in the sample.Very diluted urine specimens (as indicated by low specific gravity) may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is suspected, a first-morning urine specimen should be collected 48 hours later and tested.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and lab findings have been evaluated.

• 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: 7967839
• MDR Text Key: 123804712
• Report Number: 2027969-2018-00137
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)200430(10)HCG8050159
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: FHC-102
• Device Lot Number: HCG8050159
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/15/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention