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

Catalog Number 28122474001

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received values that were twice as high for an unspecified number of patient samples tested for tina-quant hemoglobin a1c gen.2 (hba1c).The high results were seen while using one specific reagent cassette.After noticing the situation, the customer repeated the samples.The customer provided data for a total of eight patient samples that had erroneous hba1c results.The initial results obtained with the questionable reagent cassette were reported outside of the laboratory.The first sample initially resulted as 78.20 mmol/mol.The sample was repeated, resulting as 43.0 mmol/mol.The sample was repeated a second time on a different integra analyzer, resulting as 45.8 mmol/mol.The second sample initially resulted as 72.05 mmol/mol.The sample was repeated, resulting as 46.0 mmol/mol.The sample was repeated a second time on a different integra analyzer, resulting as 48.0 mmol/mol.The third sample initially resulted as 74.36 mmol/mol.The sample was repeated, resulting as 42.0 mmol/mol.The sample was repeated a second time on a different integra analyzer, resulting as 43.1 mmol/mol.The fourth sample initially resulted as 73.82 mmol/mol.The sample was repeated, resulting as 40.6 mmol/mol.The sample was repeated a second time on a different integra analyzer, resulting as 42.2 mmol/mol.The fifth sample initially resulted as 95.4 mmol/mol.The sample was repeated, resulting as 62.529 mmol/mol.The sixth sample initially resulted as 87.3 mmol/mol.The sample was repeated, resulting as 54.197 mmol/mol.The seventh sample initially resulted as 87.5 mmol/mol.The sample was repeated, resulting as 54.276 mmol/mol.The eighth sample initially resulted as 69.4 mmol/mol.The sample was repeated, resulting as 39.5507 mmol/mol.It was asked, but it is not known if any patients were adversely affected.No adverse events were alleged.The hba1c reagent lot number was 608985.The reagent expiration date was asked for, but not provided.A specific root cause could not be determined based on the provided information.A general problem with the reagent can be excluded.

• 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: 5223512
• MDR Text Key: 31194440
• Report Number: 1823260-2015-04541
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 28122474001
• 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