MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HBA1C III TINA-QUANT HEMOGLOBIN A1C III; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number HBA1C TQ G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

There was a complaint of a questionable hba1c iii tina-quant hemoglobin a1c iii result for 1 patient tested with a cobas 4000 c311 stand alone system.The questionable result was reported outside the laboratory, and a correction was sent.The customer alleges the issues started with a new reagent pack.The patient¿s initial result was 6.1%; the repeat was 7.4%.The customer believes the repeated result to be correct.The hba1c iii tina-quant hemoglobin a1c iii used was lot 543874 and the expiration date was requested, but not provided.The cobas 4000 c311's serial number is (b)(4).

Manufacturer Narrative

The customer changed calibration material, water, and the reagent pack as troubleshooting.They had the same issue.There was a calibration flag that indicated deteriorated calibrator or reagent pack.There are no further issues reported.The investigation is ongoing.

Manufacturer Narrative

The qc was recovering low and did not meet acceptance criteria on (b)(6) 2021.The reagent pack was last calibrated on (b)(6) 2021.The investigation found calibration alarms on the calibration documentation.The customer had preventative maintenance performed on the analyzer on (b)(6) 2021.A replacement calibrator pack sent for troubleshooting purposes resolved the issue.There have been no further issues reported.

• Brand Name: HBA1C III TINA-QUANT HEMOGLOBIN A1C III
• 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: 12771344
• MDR Text Key: 286339001
• Report Number: 1823260-2021-03252
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 543874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• 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