MAUDE Adverse Event Report: ROCHE DIAGNOSTICS A1C-3; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number HBA1C TQ G3

Device Problem High Test Results (2457)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

The initial reporter questioned high results for 2 samples from 1 patient tested for a1c-3 on a cobas 8000 c 502 module.On approximately (b)(6) 2022 the result from the c502 module was 31.8%.This result was reported outside of the laboratory where it was considered to be not believable.This sample was repeated by an unspecified chromatography method and the result was 17.8%.This result was believed to be correct.On (b)(6) 2022 a 2nd sample was obtained and the result from the c502 module was 28.7%.Sometime during the week of (b)(6) 2022 another sample was obtained from the patient and the result from the c502 module was 17.1% which corresponds to the result from the chromatography method.On (b)(6) 2022 the customer repeated another sample from the patient on the c502 module and the result was 16.8% which corresponds to the result from the chromatography method.The c502 module serial number was (b)(4).

Manufacturer Narrative

No further information or data was provided by the customer.Sample material was requested for investigation but was no longer available to send.From the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: A1C-3
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13975880
• MDR Text Key: 289735392
• Report Number: 1823260-2022-00928
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• 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: AMOXICILLIN/CLAVULANIC ACID (AMOXYCLAV); CARVEDILOL; CLEXANE; FUROSEMIDE; INSULIN; RAMIPRIL