MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E602

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for elecsys ferritin (ferr) on a cobas 8000 e 602 module (e602).The sample initially resulted as 1952 ng/ml and this value was reported outside of the laboratory to the physician.The physician questioned the result, so the sample was repeated.The sample was diluted times 400 and repeated, resulting as 794873 ng/ml.The repeat result was believed to be correct.The patient was not adversely affected.The ferr reagent lot number was 192154.The reagent expiration date was asked for, but not provided.The field service engineer determined that the pinch tubing was possibly worn.He changed syringe seals and pinch tubing.He performed a complete decontamination of the analyzer and performed preventive maintenance.He ran precision studies.The customer ran controls and results were within their specified ranges.

Manufacturer Narrative

Calibration signals were within expectations.Quality control recovery was within expectations.A general reagent issue can be excluded since controls recover within expectations.Sample dilution at a 1:400 ratio is not recommended.Product labeling recommends a 1:50 dilution.There is no high dose hook effect with the ferr assay at concentrations up to 100000 ng/ml.The issue is most likely related to the worn out pinch tubing found by the field service engineer.

• Brand Name: COBAS 8000 E 602 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 6903367
• MDR Text Key: 87765430
• Report Number: 1823260-2017-02143
• Device Sequence Number: 0
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 10/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E602
• Device Catalogue Number: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 10/12/2017
• 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
• Patient Age: 23 YR