MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL HEALTH RAPID TEST HCG CASS. 30T; PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation conclusion.Devices not returned.Customer unresponsive.

Event Description

(b)(6) 2019: a (b)(6) old patient presented to the clinic for an intrauterine contraceptive device (iud).The patient's urine was collected and tested on the cardinal health hcg cassette rapid test at 4:12 pm and provided a negative result.The patient underwent iud insertion.(b)(6) 2019: the patient called the clinic to report abdominal pain.(b)(6) 2019: the patient visited the clinic and an ultrasound was performed and determined the patient had an ectopic pregnancy.Although further information was requested, customer was unresponsive and no further information was able to be obtained.Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique, storage conditions and patient specific factors per the package insert (pi).Technical services specialist informed customer per the pi: transfer 3 drops of urine in the cassette.Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.False negative results may occur when the levels of hcg are below the sensitivity level of the test and very dilute urine specimens, as indicated by specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first-morning urine specimen should be collected 48 hours later and tested.Run controls on each new lot, each new shipment, monthly as a check on storage, each new untrained operator, and as otherwise required by your lab internal quality system procedures.

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retained devices from the reported lot number.Retained devices were tested with qc cutoff standard (25 miu/ml) and clinical high hcg-positive (200.6-214.6 iu/ml) urine samples.Results were read at 3 minutes and all devices produced expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.It was reported that 3-4 drops of the patient urine sample was transferred to the test.Per the package insert, transfer 3 full drops of urine (approx.100 ul) to the specimen well of the test cassette.No further deviations regarding product storage and testing technique were observed.The reported issue was not replicated as retention product performed as expected.A probable cause could not be determined based on the information available.As stated in the product insert, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.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 level 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: CARDINAL HEALTH RAPID TEST HCG CASS. 30T
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9267686
• MDR Text Key: 189226671
• Report Number: 2027969-2019-00598
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)201031(10)HCG8110009
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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: 10/31/2020
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG8110009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 77