MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 05122287001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Initial reporter: the phone number was noted to be (b)(6) and the fax number was noted to be (b)(6).

Event Description

The customer provided questionable results for bilirubin on 15 samples and glucose on 1 sample for 5 neonatal patients.Of the results provided, the glucose result was erroneous.The glucose sample includes what appears to be an erroneous blood glucose of 40 on the cobas b 123 and what appears to be a blood glucose of 65 from the same sample on another method.The units of measure for the results was requested but not provided.When asked about the glucose results the customer stated they did not wish to complain about the glucose results.There is no information available regarding any actions taken or medications given for the glucose results reported.The glucose reagent lot number was requested but not provided.There was no adverse event.

Manufacturer Narrative

Upon investigation of the available data, there was no indication that the glucose measurement result obtained on the cobas b 123 analyzer was not correct.There was no indication of a product malfunction for this parameter.

• Brand Name: COBAS B 123 <4> SYSTEM
• Type of Device: BLOOD GAS 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: 5816042
• MDR Text Key: 50297185
• Report Number: 1823260-2016-01044
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111188
• 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,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• 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: 1 DA