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

Model Number C503

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable results from the cobas pro c 503 analytical unit.The tech noticed the low results and decided to perform repeat testing on the other c503 module in the laboratory.Patient 1 initial total protein result was 0.559 g/l and the repeat result was 5.39 g/l.Patient 2 initial glucose result was 43.5 mg/dl and the repeat result was 148 mg/dl.The initial creatinine result was 0.116 mg/dl and the repeat result was 0.98 mg/dl.The initial total protein result was 1.22 g/l and the repeat result was 6.22 g/l.Patient 3 initial glucose result was 26.8 mg/dl and the repeat result was 113 mg/dl.The questionable results were not reported outside of the laboratory.The glucose reagent lot number was 596374, the creatinine reagent lot number was 577467, and the total protein reagent lot number was 619900.The expiration dates were requested but were not provided.

Manufacturer Narrative

The field service representative found a build-up of serum plasma in the sample probe from a bad sample.He cleaned and flushed out the probe.He ran successful mechanical checks, calibrations, and qc.As the calibration and qc data were acceptable, there was no indication of a reagent issue.The centrifuge time may be too short and the speed may be too high per the tube manufacturer¿s recommended guidelines.The investigation determined the service actions resolved the issue.

• 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: 14335310
• MDR Text Key: 299865842
• Report Number: 1823260-2022-01313
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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: 06/13/2022
• 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