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

Catalog Number	05122287001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer performed comparison measurements between the cobas b 123 < 4 > poc system and cobas b 123.The field service engineer (fse) detected a clog in the cuvette of the system at the time of this measurement.He then corrected this issue.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ph, pco2, po2, and glucose results from one patient sample tested on the cobas b 123 < 4 > poc system.The patient sample was rerun on the cobas b 123 < 4 > poc system and on the cobas b 221.The initial result was reported to the medical personnel treating the patient.Refer to the attachment in the medwatch for the highlighted questionable results.The electrode lot numbers and expiration dates were requested but not provided.
Additional Manufacturer Narrative
Based on the qc data provided, the investigation determined that the po2 qc failed from (b)(6)-2022 to (b)(6)2022."product labeling states failure to follow qc protocols or ignoring qc results may lead to incorrect patient results failure to follow qc protocols or ignoring qc results may lead to incorrect patient results, which may endanger patient lives.Follow quality control practices according to local regulations." "if a parameter is not calibrated, no qc evaluation can take place.If this occurs, calibrate the parameter and repeat the qc measurement." the investigation did not identify a product problem.

• Brand Name: COBAS B 123 <4> POC SYSTEM
• Common Device Name: 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15201274
• Report Number: 1823260-2022-02391
• Device Sequence Number: 6413181
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 04015630036950
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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 Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASS 100; BERLTHYROX; BISOHEXAL; DELIX; ENOXAPARIN (CLEXANE); FORXIGA; FUROSEMID (FURORESE); KRISTALLINE E 153; LANTUS; LEVOFLOXACIN (TAVANIC); MIXED INFUSIONS - FREKA VIT FETTL; MIXED INFUSIONS - FREKA VIT WASS.; MIXED INFUSIONS SMOF KABIVEN ZENTRAL; NUTRISON DIASON; PANTOPRAZOL (PANTOZOL); PERFUSORS - ACTRAPID; PERFUSORS - NORADRENALIN; SIMVASTATIN; WASSER; ZYVOXID
• Patient Age: 64 YR
• Patient Sex: Female