MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number C503

Device Problems Unable to Obtain Readings (1516); Low Test Results (2458)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the issue was caused by insufficient probe cleaning, leading to contamination of the sample probe.The issue was resolved by the service actions.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested for multiple analytes on the cobas pro c 503 analytical unit.Results from the following assays were affected: gluc3 glucose hk gen.3, hdlc4 hdl-cholesterol plus 4th generation, crep2 creatinine plus ver.2, ua2 uric acid ver.2, and chol2 cholesterol gen.2.No incorrect results were reported outside of the laboratory.The repeat values were comparable to previous results of the patients.The first patient sample initially resulted in a glucose value of 38.0 mg/dl, which repeated as 77.9 mg/dl.The second sample initially resulted in an hdl value of 42.2 mg/dl, which repeated as 68.1 mg/dl.The second sample initially resulted in a glucose value of 42.3 mg/dl, which repeated as 115 mg/dl.The second sample initially resulted in a creatinine value of 0.449 mg/dl, which repeated as 1.14 mg/dl.The second sample initially resulted in a uric acid value of 4.29 mg/dl, which repeated as 5.83 mg/dl.The third sample initially resulted in a cholesterol value of 85.7 mg/dl, which repeated as 179 mg/dl.The glucose reagent lot was 551267, the hdl reagent lot was 530537, the creatinine reagent lot was 577467, the uric acid reagent lot was 574816, and the cholesterol reagent lot was 559813.The reagent expiration dates were requested, but not provided.

Manufacturer Narrative

Precision studies were performed and were very good.The field service engineer found the sample probe to be very dirty.The probe was cleaned and the probe rinse water level was adjusted.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13020497
• MDR Text Key: 285454193
• Report Number: 1823260-2021-03754
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K191899
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C503
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• 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