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

Catalog Number 28122474692

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

The customer reported that they received questionable results for an unspecified number of patient samples tested for tina-quant hemoglobin a1c gen.2 (hba1c).The customer stated that results were reported outside of the laboratory where they were questioned by a doctor.Approximately 12 corrected reports were needing to be issued.The customer provided an example for one patient sample that had an erroneous hba1c result.The sample initially resulted as 9.1 % and this value was reported outside of the laboratory where it was questioned by a doctor.The sample was repeated on (b)(6) 2015, resulting as 4.6 %.The repeat result was believed to be correct and a corrected report was issued.The patient was not adversely affected.The hba1c reagent lot number was 60965801, with an expiration date of 06/30/2016.The field service representative determined that there was a fluidic failure of a sample probe.He replaced the probe.He ran quality controls and all were good.He ran a patient correlation with another integra analyzer and all results matched.

• Brand Name: COBAS INTEGRA 800
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5223645
• MDR Text Key: 31180674
• Report Number: 1823260-2015-04540
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28122474692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 10/29/2015
• 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