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

Model Number	FHC-102
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving a total of five false positive hcg results on cardinal rapid test hcg cassettes while testing five patients.Each patient presented to the emergency department for an unspecified reason.A serum sample was collected from "patient 3" on (b)(6) 2024 at 1120 and no visible anomalies were observed regarding the sample appearance.The customer reported a timer was used, the test was performed per the package insert and false positive hcg results were obtained.Confirmatory testing was performed which yielded a negative beta hcg result.No adverse events were reported; however, each patient experienced a 1-2 hour delay as confirmatory testing was performed.No further information was provided.See mdrs 2027969-2024-00050, 2027969-2024-00051, 2027969-2024-00053 and 2027969-2024-00054 for the other related patients.
Additional Manufacturer Narrative
Results pending completion of the investigation.
Additional Manufacturer Narrative
B5- describe event or problem was updated to indicate based on the information provided this event is not reportable as an incorrect sample type was used and no adverse events were reported.Investigation conclusion: retained devices from the reported lot number 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.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.Case details indicate false positive results were obtained while using serum samples.Per the packaging insert, the hcg cassette rapid test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hcg) in urine to aid in the early detection of pregnancy.Use of incorrect sample type cannot be ruled out as the cause of the reported issue.Complaints are tracked and trended on a monthly basis.
Event or Problem Description
The customer reported receiving a total of five false positive hcg results on cardinal rapid test hcg cassettes while testing five patients.Each patient presented to the emergency department for an unspecified reason.A serum sample was collected from "patient 3" on (b)(6) 2024 at 1120 and no visible anomalies were observed regarding the sample appearance.The customer reported a timer was used, the test was performed per the package insert and false positive hcg results were obtained.Confirmatory testing was performed which yielded a negative beta hcg result.No adverse events were reported; however, each patient experienced a 1-2 hour delay as confirmatory testing was performed.No further information was provided.See mdrs 2027969-2024-00050, 2027969-2024-00051, 2027969-2024-00053 and 2027969-2024-00054 for the other related patients.Upon further review it was noted that initial emdrs were not required as the customer used an incorrect sample type (serum) and no adverse events were reported.According to the package insert, the hcg cassette rapid test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hcg) in urine to aid in the early detection of pregnancy.

• Brand Name: CARDINAL RAPID TEST HCG CASSETTE
• Common Device Name: 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: 19256005
• Report Number: 2027969-2024-00052
• Device Sequence Number: 16815613
• Product Code: JHI
• UDI-Device Identifier: 20885380020251
• UDI-Public: (01)20885380020251(17)250830(10)0000776152
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2025
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: 0000776152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female