MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P (701) POST ANALYTICAL SYSTEM; AUTOMATED POST ANALYTICAL SYSTEM

Model Number P 701

Device Problem Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer alleged an issue with patient sample identification on the cobas p 701 post analytical unit.The customer stated they could not retrieve the sample because the cobas p701 misread the sample barcode and truncated the last 4 digits of the sample id.When the tube was processed, the barcode (b)(6) was not completely decoded.Only the first 8 characters were decoded and the sample was stored with the sample id 10024441.The p701 was configured to accept 7 to 14 digits.There was no error message and the sample was accepted for storage since the barcode was within the configured length.There was no allegation of an adverse event.

Manufacturer Narrative

The investigation determined that the "interleaved barcode without check digits" that was used has the risk of incomplete readings.The barcode length was not limited to the number of digits that were used.It is recommended to limit the digits to a minimum of 10 and a maximum of 12.The field service engineer changed the settings and the issue has not occurred again.No diagnostic test results were affected and a medical risk to the patients and users can be excluded.

• Brand Name: COBAS P (701) POST ANALYTICAL SYSTEM
• Type of Device: AUTOMATED POST ANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7536588
• MDR Text Key: 109501446
• Report Number: 1823260-2018-01588
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P 701
• Device Catalogue Number: 05349966001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1