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

Catalog Number 03337154001

Device Problem Low Test Results (2458)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received a questionable total hemoglobin (thb) result for one patient with a cobas b221 analyzer when compared to a xn 1000 hematology instrument.Of the data provided, there were erroneous results for the thb and hematocrit (hct) tests.The thb result from the cobas b 221 was 5.45 g/dl.The thb result using the same sample in another laboratory with an xn 1000 instrument was 9.60 mg/dl.The hct result from the b 221 was 15.0%.The hct result using the same sample in another laboratory with an xn 1000 instrument was 29.50%.The customer stated they observed this same issue with a different sample on (b)(6) 2018.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The qc results were checked and determined to be acceptable.The customer stated that they used "factory heparinized syringes".The lot number and expiration date of the thb cuvette was requested but was not provided.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The customer was using a "clot catcher".The "factory heparinized syringe" was a bs2 blood sampler.

• 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: 7326478
• MDR Text Key: 102218688
• Report Number: 1823260-2018-00734
• 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,Followup,Followup
• Report Date: 05/01/2018

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: 02/20/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 02/20/2018; 02/20/2018
• Supplement Dates FDA Received: 03/20/2018; 04/04/2018; 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR