MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of multiple sample up/down alarms and an erroneous low result for 1 patient tested for phos2 phosphate (inorganic) ver.2 (phos2) on a cobas 6000 c (501) module.The initial phos2 result was 0.1 mg/dl with a data flag.The lab tech was not paying close attention and reported the result outside of the laboratory.The sample was repeated on a different analyzer and the result was 4.2 mg/dl.The repeat result was believed to be correct and a corrected report was issued.The patient was treated with phosphorus based on the initial phos2 result reported outside of the laboratory.There was no allegation that an adverse event occurred due to this treatment.The customer stated there were other erroneous results reported outside of the laboratory.The customer did not have the specific results, however, the repeat results were not deemed to be clinically significant when compared to the results initially reported outside of the laboratory.The only clinically significant result the customer had was the low, erroneous phos2 result.The phos2 reagent lot number was 19635201 with an expiration date of 01/31/2018.The customer checked the sample probe and found that there was gel in it.The customer does not have another probe so she will clean the probe.The field service engineer visited the customer site after the customer had cleaned the sample probe.The fse ran a pipetting accuracy check.The customer ran quality controls.The results from all instrument tests were acceptable.

Manufacturer Narrative

The investigation determined that the root cause of the issue was the gel on the sample probe that the operator found.

Manufacturer Narrative

Medical assessment of the event was performed and noted that the initial phos2 result was accompanied by a data flag and should not have been reported outside of the laboratory.The decision to treat the patient after one questionable, plausible result could not be addressed as the medical background of the patient is not known (e.G.Kidney disease, patient in intensive care unit).A product problem was not identified.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 6619626
• MDR Text Key: 77307075
• Report Number: 1823260-2017-01167
• Device Sequence Number: 0
• Product Code: CEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1