MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI S; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's age was provided as "newborn baby".The investigation determined that the qc was acceptable before and after the event.The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of a questionable bilirubin result for a newborn patient tested on a cobas b 221 instrument compared to the siemens advia 1800.At 06:34 the bilirubin result on the b 221 from a "blood gas tube" was 267 umol/l.At 06:34 the bilirubin result on the advia from a serum sample "gel tube" was 322 umol/l.The customer stated that the sample was collected for the advia at 06:38.No questioned result was reported outside of the laboratory and the advia result was considered correct.

Manufacturer Narrative

The investigation found no indication of an aspiration issue.The performance data show no indication of a system issue.The investigation determined at the time of measurement, the cobas b221 was working within specifications.The malfunction is consistent with a pre-analytical handling issue.No product problem was found.The cause of the event could not be determined.

• Brand Name: ROCHE OMNI S
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8882890
• MDR Text Key: 154032080
• Report Number: 1823260-2019-02926
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1