MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA 400 PLUS; CLINICAL CHEMISTRY ANALYZER

Model Number I400+

Device Problem High Test Results (2457)

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

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4) medwatch phone number was provided as (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for gluc3 glucose hk (gluc) on an cobas integra 400 plus (i400+).The erroneous results were not reported outside of the laboratory.The sample had a low volume.The sample initially resulted as 234.7 mg/dl.The sample was repeated twice, resulting as 286 mg/dl and 158.5 mg/dl respectively.The third repeat result was 162 mg/dl, which was considered to be correct and reported outside of the laboratory.No adverse events were alleged to have occurred with the patient.The gluc reagent lot number was 236290.The reagent expiration date was asked for, but not provided.The field service engineer checked the analyzer hardware and sample probe.These were ok.The gluc assay was successfully calibrated on (b)(6) 2017.Between 19-aug-2017 and 27-aug-2017, the level 1 quality control was within range, but there was a large variation in results.Between 27-aug-2017 and 29-aug-2017, the level 1 quality control was close to target and showed higher precision.The level 2 quality control was within range.

Manufacturer Narrative

The customer changed the sample probe after the event.After this, the issue no longer occurred.Based on the provided information, the root cause of the issue is a contaminated sample probe.

• Brand Name: COBAS INTEGRA 400 PLUS
• 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: 6869134
• MDR Text Key: 86601735
• Report Number: 1823260-2017-02004
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I400+
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• 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: 88 YR