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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 10/13/2019

Event Type  malfunction  

Manufacturer Narrative

Devices not returned.Customer to monitor - troubleshooting provided.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-conformances; 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.Case details indicate the samples were not first morning urine collections.Insufficient information was provided to determine deviations in technique or sample related issues as the number of drops used on the test, the interpretation time and the sample's color/clarity was not provided.As stated in the product insert, transfer 3 full drops of urine (approx.100 ul) to the specimen well of the test cassette.Read the result at 3-4 minutes.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.

Event Description

(b)(6) 2019: patient presented to facility for a yeast infection, dysuria, genitourinary (gu) complaints, medication administration and for her period being two days late.Urine specimen was tested on the cardinal health hcg urine cassette at 9:33 pm and a negative result was obtained.(b)(6) 2019: at home pregnancy test provided a positive result.Urine specimen was tested on the cardinal health hcg urine cassette at 7:09 pm and a negative result was obtained.(b)(6) 2019: pregnancy confirmed.Confirmatory method and exact result not provided.(b)(6) 2019: urine specimen was tested on the cardinal health hcg urine cassette at 2:49 pm and a negative result was obtained.Confirmatory hcg test provided a positive result of 82 miu/ml (b)(6) 2019: positive urine pregnancy result obtained (method not provided) (b)(6)2019: confirmatory hcg provided a positive result of 609 miu/ml although further information was requested, no further information was able to be provided regarding patient outcome.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: very diluted urine specimens (as indicated by 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.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: CARDINAL HEALTH RAPID TEST HCG CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052506
• MDR Report Key: 9338755
• MDR Text Key: 188857776
• Report Number: 2027969-2019-00594
• Device Sequence Number: 1
• Product Code: JHI
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/18/2019
• 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 Age: 24 YR
• Patient Weight: 78