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

Model Number HBA1C TQ G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer checked the analyzer and found no issues.The reporter also borrowed another pack of the same lot from a sister site and was able to calibrate, run controls, and run patient samples without issue.This issue was resolved by replacement of the reagent pack.The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated that they noticed a high bias in quality control and patient results when using a new lot of a1c-3 tina-quant hemoglobin a1c gen.3 on the cobas 6000 c (501) module.When switching to this new lot number on (b)(6) 2019, the reporter performed a comparison study with the older lot number and this passed.The reporter placed a new reagent pack of the same lot on the analyzer on (b)(6) 2019, re-calibrated, and ran controls.Calibration values were lower.The reporter then repeated patient samples on (b)(6) 2019.The reporter provided data for patient samples and of these, four had discrepant hemoglobin a1c results.The initial values for these samples were reported outside of the laboratory.The repeat results were measured on (b)(6) 2019 and these results were believed to be correct.Corrected reports were issued.The first sample initially resulted with a hemoglobin a1c result of 9.6 %, which repeated as 8.7 %.The second sample, from a (b)(6) year old male patient born on (b)(6) initially resulted with a hemoglobin a1c result of 6.8 %, which repeated as 6.1 %.The third sample, from an (b)(6) year old male patient born on (b)(6), initially resulted with a hemoglobin a1c result of 10.2 %, which repeated as 8.9 %.The fourth sample, from a (b)(6) year old male patient born on (b)(6), initially resulted with a hemoglobin a1c result of 6.6 %, which repeated as 5.9 %.The serial number of the c 501 analyzer is (b)(4).

• 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: 9473797
• MDR Text Key: 219773855
• Report Number: 1823260-2019-04431
• Device Sequence Number: 1
• Product Code: LCP
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: HBA1C TQ G3
• Device Catalogue Number: 05336163190
• Device Lot Number: 42079801
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR