MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL RAPID TEST HCG COMBO; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical serum and 2miu/ml hcg serum samples.The results of the devices containing hcg-negative clinical serum were read at 5 and 6 minutes and all devices yielded valid negative results with strong control lines.Additionally, the results of the devices tested with 2miu/ml hcg serum samples were read at 6 minutes and yielded negative results.No false positive 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.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control 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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: very low levels of hcg (less than 50 miu/ml) are present in serum and urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning serum or urine specimen collected 48 hours later.A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in a serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.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.H3 other text : although requested, device return is not anticipated.

Event Description

The customer reported receiving false positive hcg results while using the cardinal rapid test hcg combo tests.The patient presented to the hospital due to anorexia, bradycardia and possible malnutrition.A serum sample was collected which appeared clear yellow in color.The customer reported a timer was used, the results were read at 5 minutes, and a faint false positive result was observed.The same sample was retested using two additional devices from the same lot and additional false positive results were observed.According to the customer, confirmatory testing was performed and a quantitative analysis yielded a concentration of <1.2miu/ml.The patient provided an additional serum sample and testing with devices from the same lot yielded negative results.As a result, the customer reported treatment was delayed, however no adverse events were reported.No further information was provided.

• Brand Name: CARDINAL RAPID TEST HCG COMBO
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 18116718
• MDR Text Key: 327879084
• Report Number: 2027969-2023-00103
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)240229(10)HCG2032067
• 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
• Type of Report: Initial
• Report Date: 11/10/2023

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: 02/29/2024
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG2032067
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 16 YR
• Patient Sex: Female