MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HBALC GEN. 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 06/01/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable hba1c tq gen.3 results on a cobas integra 400 plus analyzer.Due to a client questioning reported hba1c results, the reporter repeated previous patient samples on the same analyzer.For patient sample #(b)(6), the initial hba1c result was 8.1%.The repeat hba1c result was 6.4%.The initial result was reported outside of the laboratory.The sample was collected and initially run on (b)(6) 2022.The repeat test was performed on the same sample and analyzer on (b)(6) 2022.The instrument serial number is (b)(4).

Manufacturer Narrative

The field service engineer (fse) performed a precision study that was acceptable.The fse found that wash probe c had failed the throughput check and was not dispensing fluid.He replaced two valves, reseated and replaced boards, and replaced the cassette sense lock module.The customer successfully performed calibration and qc.As the qc recovery was within 2sd, there was no indication of a performance issue of the reagent.The service actions performed by the fse resolved the issue.

• Brand Name: TINA-QUANT HBALC GEN. 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: 14715740
• MDR Text Key: 301859966
• Report Number: 1823260-2022-01758
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: 59190201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female