MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MEDLINE HCG COMBO CASSETTE; 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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.B3 - date of event: listed as 11/1/2023 as an event date was not provided.H3 other text : although requested, device return is not anticipated.

Event Description

The customer reported receiving several false positive hcg results while using kits from two lots of medline hcg combo cassette tests.The customer reported receiving positive results when negative results are expected.No further information was provided.No adverse events reported.See mdr 2027969-2023-00119 for lot 0000674186.

Manufacturer Narrative

B3 - date of event: listed as (b)(6) 2023 as an event date was not provided.D4 - expiration date: previously submitted as ni and now has been updated with the expiration date.D4 - unique identifier (udi) #: previously submitted as blank and now has been updated with the udi.G1 - contact office postal code: previously submitted as blank and now has been updated.H4 - device mfg date: previously submitted as blank and not has been updated.H6 - adverse event problem: has been updated as the investigation was completed.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and serum samples.The results were read at 3 and 4 minutes for urine samples and 5 and 6 minutes for serum samples.All devices yielded valid 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 mlu/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 several false positive hcg results while using kits from two lots of medline hcg combo cassette tests.The customer reported receiving positive results when negative results are expected.No further information was provided.No adverse events reported.See mdr 2027969-2023-00119 for lot 0000674186.

• Brand Name: MEDLINE HCG COMBO CASSETTE
• 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: 18270754
• MDR Text Key: 329758411
• Report Number: 2027969-2023-00120
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191884
• UDI-Public: (01)30884389191884(17)250130(10)0000674182
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Catalogue Number: MPH22025HCG
• Device Lot Number: 0000674182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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