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

Catalog Number 05122287001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

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 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.

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
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15201274
• MDR Text Key: 305247135
• Report Number: 1823260-2022-02391
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 04015630036950
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/18/2022
• 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
• Patient Sequence Number: 1
• Treatment: 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