MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URINE/SERUM COMBO; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-A202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported receiving a false negative hcg result while using the consult hcg combo test.The customer reported the patient presented to the hospital due to vaginal bleeding.A fresh urine sample was collected which the customer reported yielded a negative result.Additionally, a catheter urine sample and serum sample were collected using the consult hcg combo test and positive hcg results were obtained.It was not specified when the patient went into labor, however it was reported that the patient gave birth on the same day.No adverse events were reported.
Additional Manufacturer Narrative
Results pending completion of the investigation.H3 other text : although requested, device return not anticipated.
Event or Problem Description
The customer reported receiving a false negative hcg result while using the consult hcg combo test.The customer reported the patient presented to the hospital due to vaginal bleeding.A fresh urine sample was collected which the customer reported yielded a negative result.Additionally, a catheter urine sample and serum sample were collected using the consult hcg combo test and positive hcg results were obtained.It was not specified when the patient went into labor, however it was reported that the patient gave birth on the same day.No adverse events were reported.
Additional Manufacturer Narrative
H2 - if follow-up, what type?: updated to additional information.H6 - adverse event problem: codes updated as the investigation was completed.H10 - additional mfg narrative: updated as the investigation was completed.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine, hcg-negative clinical serum, 20 miu/ml hcg urine cut-off, and 10 miu/ml hcg serum cut-off samples.The results of the negative urine samples were read at 3 and 4 minutes and the results of the negative serum samples were read at 5 and 6 minutes.All devices yielded valid negative results.The results of the cut-off hcg urine samples were read at 3 minutes and the results of the cut off serum samples were read at 5 minutes.All devices tested with cut-off samples yielded positive results.No erratic or results issues 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.Please note: a first morning urine specimen is preferred since it generally contains the highest concentration of hcg, however, urine specimens collected at any time of the day may be used.As a result, the concentration of hcg collected later in the day could be lower.Therefore this could lead to discrepancies between serum and urine.H3 other text : although requested, device return not anticipated.

• Brand Name: CONSULT HCG URINE/SERUM COMBO
• 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: 18025022
• Report Number: 2027969-2023-00097
• Device Sequence Number: 7759255
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)250220(10)0000679482
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2025
• Device Model Number: FHC-A202
• Device Catalogue Number: 5002
• Device Lot Number: 0000679482
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Race: Black Or African American