MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221<4>=ROCHE OMNI S4 SYSTEM; BLOOD GAS ANALYZER

Model Number	B221
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received a questionable total hemoglobin (thb) result for one patient with a cobas b 221 analyzer when compared to a medica instrument.Of the data provided, there were discrepant results for the thb and partial pressure of oxygen (po2) tests.The thb result from the b 221 was 8.4 g/dl and the repeat result from the medica instrument was 11.7 g/dl.The sample was repeated two more times on the b 221 and the results were 13.5 g/dl and 11.4 g/dl.The po2 result from the b 221 was 133.0 mmhg and the repeat result from the medica instrument was 133 mmhg.There was no allegation of an adverse event.No erroneous results were reported outside of the laboratory.The calibration and qc were acceptable.The sensor cartridge s1 lot number was 21481005 with an expiration date of 02-mar-2018 and s2 lot number was 21482019 with an expiration date of 11-nov-2018.
Additional Manufacturer Narrative
The analysis of the instrument database did not find any errors with the coox module therefore, the thb result difference for the same sample measured by cobas 221 is consistent with a pre-analytical issue.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
A syringe was used for the measurements on both instruments.The investigation is ongoing.

• Brand Name: COBAS B 221<4>=ROCHE OMNI S4 SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7922864
• Report Number: 1823260-2018-03368
• Device Sequence Number: 11144604
• Product Code: CHL
• UDI-Device Identifier: 04015630018321
• UDI-Public: 04015630018321
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K032311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

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
• Operator of Device: Health Professional
• Device Model Number: B221
• Device Catalogue Number: 03337138001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 09/13/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/15/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1