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

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting was performed with the customer.Reviewed package insert with an emphasis on: 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.It is used to aid in the early detection of pregnancy.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) which discusses the intended use and limitations of the test kit.Investigation conclusion: retention devices of the reported lot were tested with in-house clinical negative hcg urine samples.All hcg results were negative at read time and met qc specification.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Returned devices were tested with the returned urine sample.Results were read at 3-4 minutes and all devices yielded positive results with faint test lines and strong control lines.This is consistent with the customer's results.Returned device was tested with the returned serum sample.Result was read at 5 minutes and the device yielded a negative result with a strong control line.This is consistent with the customer's results.No further tests could be performed due to limited sample volume.Quantitative hcg analysis of the samples was performed.The mean of the results for the urine sample was 7.1 miu/ml.This is below the threshold of 25 miu/ml for this device and sample type.The mean of the results for the serum sample was 7.8 miu/ml.This is consistent with the negative result observed by the customer and during retention testing, as the threshold for this device and sample type is 10 miu/ml.The urine sample provided had elevated levels of protein and contained cellular debris.It is likely that the false positive result may have been reported due to an interaction with one of the biological contaminants, as the serum sample reported results correctly under the 25miu/ml threshold.Additional investigation is on-going.

Event Description

Unconfirmed false positive urine 2x as compared to a negative serum result when testing on the cardinal health hcg combo cassette kit.(b)(6) 2018: patient arrived at facility for pre-op work for a colonoscopy.Patient urine was tested twice on the cardinal health hcg combo cassette kit and positive results were obtained.The patient's serum was also tested on the cardinal health hcg combo cassette kit and a negative result was obtained.No alternate confirmatory testing performed.Patient was determined to not be pregnant based on the negative serum result obtained on the cardinal health hcg combo cassette kit.The sample was cloudy with some visible particulate matter.The cloudy urine was tested and resulted in the first positive reading.Customer then spun down the same urine sample until it was clear and tested again-resulted in positive once more.Colonoscopy may have been slightly delayed due to unconfirmed false positive urine results, however, no adverse outcomes were reported.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052804
• MDR Report Key: 8166678
• MDR Text Key: 131492952
• Report Number: 2027969-2018-00167
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)200430(10)HCG8050005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2018

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 Expiration Date: 04/30/2020
• Device Model Number: FHC-A202
• Device Lot Number: HCG8050005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 48 YR