MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 800; CLINICAL CHEMISTRY ANALYZER

Model Number I800

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received questionable results for approximately 30 patient samples tested for a1c-2 tina-quant hemoglobin a1c gen.2 (hba1c) on a cobas integra 800 (i800).Amended reports were issued for these samples since one of the patient results was questioned by the doctor.The customer provided an example of one patient sample that had an erroneous initial hba1c result that was reported outside of the laboratory.The sample initially resulted as 6.4 %.The sample was repeated on (b)(6) 2017, resulting as 5.5 %.The repeat result was believed to be correct.The patient was not adversely affected.The hba1c reagent lot number was 16445901, with an expiration date of 12/31/2017.The field service engineer could not determine a cause.He performed a check test and this passed.He observed proper analyzer function during the check test.No pipetting or measurement issues were identified.The customer confirmed that the probes were replaced recently.

Manufacturer Narrative

The samples were repeated after they had exceeded the stability requirement documented in product labeling.The repeat results are not valid.No product problem was identified.

• Brand Name: COBAS INTEGRA 800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6706767
• MDR Text Key: 80079421
• Report Number: 1823260-2017-01456
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I800
• Device Catalogue Number: 28122474692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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: 64 YR