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 08/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer obtained questionable high test results for 284 patient samples since (b)(6) 2017 using the a1cx-2 tina-quant hemoglobin a1cdx gen.2 whole blood application (hba1c) assay on the cobas integra 800 analyzer (i800).Of the 284 samples pulled and repeated on (b)(6) 2017, 142 samples repeated significantly lower than the initial result.The remaining sample results matched their initial results.Result data was provided for four patients.The customer initially discovered the issue based upon high moving average errors in their middleware, and then via physician complaints.Not all samples had moving average errors.The medical technologist ran quality controls after the high moving average errors, and it was acceptable.All initial results were released outside the laboratory.No instrument data flags or alarms occurred.Corrected reports were issued.Patient a: the initial result was 8.9%; repeat result on another i800 analyzer was 5.3%.Patient b (female, (b)(6)): the initial result was 8.1%; repeat result on another i800 analyzer was 4.96%.Patient c (female, (b)(6)): the initial result was 7.7%; repeat result on another i800 analyzer was 4.8%.Patient d (male, (b)(6)): the initial result was 8.7%; repeat result on another i800 analyzer was 5.5%.Information was provided for two additional patients.One patient was prescribed unspecified medication based upon their results.Another patient was diagnosed with diabetes (type not provided) and prescribed a glucometer.The prescriptions were not filled.Result data from these patients was not provided.No adverse events occurred.The hba1c reagent lot number is 14350601 with an expiration date of 10/31/2017.Calibration and quality controls (qc) were acceptable.A review of the alarm log information found no issues.The field service representative (fsr) was unable to find a cause for the issue.He checked the rotor and workstation alignments which were acceptable.He performed a reagent flow check which passed.The sample flow check failed and he found the sample probe was clogged; however, this did not contribute to the high results.A sample flow check was performed by the customer on (b)(6) 2017 which passed.The fsr replaced the sample probe and the flow check passed.He replaced the tube stopper on the wash station due to leakage.The customer performed qc which passed.Investigation activities are ongoing.

Manufacturer Narrative

A specific root cause was not identified.A instrument problem that would cause the erroneous results was not identified.The fsr clarified that the tube stopper on the wash station was dripping and not leaking.Preventive maintenance was last performed on (b)(6) 2017 and the customer performs daily maintenance.Since calibration and quality controls were acceptable, a pre-analytic issue (improper sample storage or sample preparation and poor sample quality) cannot be excluded.These issues can cause sample probe blockages/contamination by gel or fibrin.

• 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: 6824141
• MDR Text Key: 84953971
• Report Number: 1823260-2017-01833
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I800
• Device Catalogue Number: 28122474001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• 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: 31 YR