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 Miscarriage (1962)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Date of occurrence not provided: the patient visited the clinic for a scheduled endometrial biopsy.The patient's urine was collected and tested on the cardinal health hcg cassette rapid test and resulted in a negative at 3 minutes using a timer.No confirmatory testing performed.The patient underwent the scheduled endometrial biopsy which resulted in a miscarriage.Technical services specialist (tss) made multiple attempts (4 attempts between (b)(6) 2019) to speak with customer, t.Thibodeaux, to obtain further information about the event, however, customer was unresponsive.Initial troubleshooting occurred at intake 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.Per the pi, the cardinal health hcg cassette rapid test qualitatively detects the presence of hcg in urine specimen at the sensitivity of 25 miu/ml.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.

Manufacturer Narrative

Investigation conclusion: although a lot number could not be obtained, an investigation was performed on all retained lots of this product within expiration.Retained devices were tested with qc cutoff standard (25 miu/ml) and clinical high hcg-positive (206.17-217.10 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-conformance's; the lots 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 were transferred to the test.The package insert instructions require three full drops of urine (approximately 100 ul) added 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 package 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: 9274835
• MDR Text Key: 165400816
• Report Number: 2027969-2019-00588
• Device Sequence Number: 1
• Product Code: JHI
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other