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

Catalog Number 05336163190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received questionable results for an unspecified number of patient samples tested for a1c-3 tina-quant hemoglobin a1c gen.3 (hba1c) on a cobas 6000 c (501) module - c501.Of the questioned samples, one patient sample had an erroneous hba1c result reported outside of the laboratory.The patient received treatment based on the erroneous result.The customer stated that the issue began when they started using a new reagent pack of the same lot number.No calibration was run on this new pack.Quality controls with an acceptable recovery were also not generated on the pack.The pack was on board the analyzer as a stand-by pack prior to being used.The sample initially resulted with an hba1c value of 6.8% and this value was reported outside of the laboratory.The sample was repeated, resulting as 5.3 %.The repeat result was believed to be correct.The patient received treatment for a diabetic protocol based on the erroneous result.The customer was asked, but could not provide any information on whether the patient was adversely affected due to this treatment.No adverse events were alleged to have occurred with the patient.The c501 analyzer serial number was (b)(4).The field application specialist was on site and instructed the customer to place a new reagent pack on board.The placed a new pack on board and ran controls.Controls passed and the customer did not encounter any further issues.The customer declined further service.

Manufacturer Narrative

The patient is not known to have diabetes.Other reagent packs from the same lot did not show any incorrect results at the customer site.A general reagent issue can be excluded.The customer did not use recommended rack adapters for 13 mm diameter tubes.The investigation was unable to find a definitive root cause.

• 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
• MDR Report Key: 7532954
• MDR Text Key: 109374625
• Report Number: 1823260-2018-01577
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 05336163190
• Device Lot Number: 30116701
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR