MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE 25T; PREGNANCY TEST

Model Number 9004073

Device Problem False Negative Result (1225)

Patient Problems Menstrual Irregularities (1959); Miscarriage (1962); Urinary Tract Infection (2120)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Troubleshooting was conducted with the customer.The directions for use and limitations sections of the package insert were discussed with specific emphasis on the following: allowing the test cassette, urine specimen and/or controls to equilibrate room temperature (15-30°c/59-86°f) prior to testing.Very dilute urine specimens, as indicated by a low specific- gravity, may not contain representative levels of hcg.If pregnancy is suspected, a first morning urine specimen should be collected 48 hours later and tested.Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.Reviewed hcg product information notice (pin) with customer which discusses the intended use and limitations of the test.Investigation conclusion: retention products for the reported lot number were tested with cut-off hcg urine standard (25 miu/ml) and clinical high hcg urine (212.3, 215.2, 221.9 iu/ml).All devices produced expected positive results at the read time.No false negative results were observed during testing.Manufacturing batch record review did not uncover any abnormalities and qc data met specifications.The reported complaint for false negatives was not replicated as retention products performed as expected.Per the package insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity of the test.When pregnancy is still 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 laboratory findings have been evaluated.

Event Description

On (b)(6) 2018, the patient arrived at the clinic to confirm a positive pregnancy result obtained on a home pregnancy test.The complainant is unable to provide specifics regarding the home pregnancy test kit used or date the test was performed.A cloudy urine sample was collected from the patient and a negative result was interpreted on the henry schein one step+ hcg urine cassette test.A urinalysis test was also performed on the urine sample and the complainant stated it was positive for a urinary tract infection (uti).The patient was prescribed bactrim (us fda pregnancy category: d) for the uti and was discharged from the clinic.Later in the day on (b)(6) 2018, the patient experienced vaginal bleeding after being discharged from the clinic.The patient went to the emergency room (er) department of another medical facility, helena regional medical center.Though the patient was prescribed bactrim to treat her uti, she had not taken any of the medication prior to the er visit.Positive hcg results were obtained on unspecified confirmatory tests using urine and blood samples.The complainant is unable to provide the confirmatory test methods used and the exact quantitative results of the tests.The complainant does not have details regarding the treatment provided to the patient in the er.Complainant states bactrim would not have been prescribed to the patient if the henry schein one step+ hcg urine cassette pregnancy test had been positive.Complainant states patient is no longer pregnant and confirms she had a miscarriage.

Manufacturer Narrative

Investigation conclusion: retention products for the reported lot number were tested with cut-off hcg urine standard (25 miu/ml) and clinical high hcg urine (212.3, 215.2, 221.9 iu/ml).All devices produced expected positive results at the read time.No false negative results were observed during testing.Manufacturing batch record review did not uncover any abnormalities and qc data met specifications.The reported complaint for false negatives was not replicated as retention products performed as expected.It was identified that the product was used prior to the product reaching room temperature.As stated in the directions for use, "allow the test cassette, urine specimen and/or controls to equilibrate to room temperature (15-30°c/59-86°f) prior to testing.Per the package insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity of the test.When pregnancy is still 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 laboratory findings have been evaluated.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 25T
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 8127224
• MDR Text Key: 129152605
• Report Number: 2027969-2018-00157
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 10304040024109
• UDI-Public: (01)10304040024109(17)200430(10)HCG8050021
• Combination Product (y/n): Y
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 9004073
• Device Catalogue Number: 4580995009
• Device Lot Number: HCG8050021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BACTRIM (STRENGTH NOT PROVIDED)
• Patient Outcome(s): Other