MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that quality controls run for tests on measuring cell 2 of the cobas 6000 e 601 module (e601) were outside of range on the evening shift.The customer prepared fresh controls and repeated them, but they still recovered outside of range.The customer pulled several samples that were tested earlier in the day and repeated them on the other e601 analyzer.The results were not the same.The customer stated that they corrected reports for a total of approximately 300 results.Of the affected patient samples, the customer provided data for a total of 14 patient samples tested for the elecsys tsh assay (tsh), elecsys ferritin (ferr), and the elecsys hcg + beta test system (hcgb).Of these samples, 9 had erroneous initial results for tsh, ferr, and hcgb that were reported outside of the laboratory.All 9 samples were repeated on the other e601 analyzer and the repeat results were believed to be correct.The first sample initially had a tsh result of 0.59 uiu/ml and repeated as 0.92 uiu/ml.The second sample initially had a tsh result of 0.05 uiu/ml and repeated as 0.01 uiu/ml.The third sample initially had a tsh result of 3.1 uiu/ml and repeated as 9.8 uiu/ml.The fourth sample initially had a tsh result of 2.3 uiu/ml and repeated as 6.8 uiu/ml.The fifth sample initially had a ferr result of 7.1 ng/ml and repeated as 12 ng/ml.The sixth sample was diluted and initially had a ferr result of 5333 ng/ml, which repeated as 8487 ng/ml.The seventh sample initially had a ferr result of 4.0 ng/ml and repeated as 8.4 ng/ml.The eighth sample initially had a ferr result of 98 ng/ml and repeated as 406 ng/ml.The ninth sample initially had an hcgb result of 27 miu/ml and repeated as 50 miu/ml.No adverse events were alleged to have occurred with the patients.The tsh, ferr, and hcgb reagent lot numbers and expiration dates were asked for, but not provided.The field service engineer found that the pinch tubing was compromised and needed to be replaced.He replaced all pinch tubing and performed measuring cell preparation maintenance.He also primed the system.The customer ran calibration and quality controls successfully.

• Brand Name: COBAS 6000 E 601 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: 6819796
• MDR Text Key: 83750549
• Report Number: 1823260-2017-01818
• Device Sequence Number: 0
• Product Code: DHA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• 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