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 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: retained devices from the reported lot number (0000621319) were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 minutes and all devices yielded valid negative results.No false positive results were observed during in-house testing.Retain device testing could not be performed on lot 000074916 as the customer provided an invalid lot number.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 (0000621319) 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.Case details indicate package insert instructions were followed, however a timer was not used.Per the package insert, a timer is required but not included.Read the result at 3-4 minutes when testing a urine specimen, or at 5-6 minutes when testing a serum specimen.Do not interpret results after the appropriate read time.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.- note: a sample hcg concentration below the cut-off level of this test might result in a weak line appearing in the test region (t) after an extended period of time.A line in the test region (t) seen after the read time could be indicative of a low hcg level in the sample.If such results are seen, it is recommended that the test be repeated with a new sample in 48-72 hours or that an alternate confirmation method is used.H3 other text : although requested, device return is not anticipated.

Event Description

The customer reported receiving three false positive results while testing three patient's using the cardinal rapid test hcg combo devices from either lot 0000621319 or 000074916.The patient indicated each patient was being tested prior to having an unspecified surgical procedure.Each patient provided a fresh urine sample which was unremarkable in appearance.Testing with the cardinal rapid test hcg combo device yielded a false positive result; as a result, the unspecified medical procedure was cancelled.The customer advised the hcg tests were performed according to the package instructions, however, the customer did not indicate the read time and indicated a timer was not used.It is unclear which patient was tested with which test lot.No adverse events were reported.No further information was provided.See mdr 2027969-2024-00010, and 2027969-2024-00012 regarding the false positives on the other 2 patients.

• 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: 18486449
• MDR Text Key: 333096212
• Report Number: 2027969-2024-00011
• Device Sequence Number: 1
• Product Code: JHI
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2023
• 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 Sex: Female