MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I ANTI-HBC II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07P87-77

Device Problem False Negative Result (1225)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The customer reported a false nonreactive alinity i anti-hbc ii result for one patient sample.The following data was provided: alinity i anti-hbc ii initial result = 0.80 s/co; repeat result = 0.77 s/co (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive).Roche anti-hbc result = 0.54 coi (reference range: coi >1.0 = non-reactive).Other testing performed: alinity i: hbsag = 0.00 (negative); anti-hbs = 1578 (positive); hbeag = 0.438 (negative); anti-hbe = 0.488 (positive).Roche: hbsag = negative; anti-hbs = positive; hbeag = negative; anti-hbe = positive.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 7p87 that has a similar product distributed in the us, list number 7p84.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: ALINITY I ANTI-HBC II REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18951753
• MDR Text Key: 338304592
• Report Number: 3002809144-2024-00082
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P87-77
• Device Lot Number: 53308BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)