MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 471 CENTRIFUGE UNIT; AUTOMATED CENTRIFUGE UNIT

Model Number P471

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

The acrylic glass handguard was not designed to be used as a handle.It is not designed to withstand the forces that are experienced when opening and closing the protective cover.In product labeling, it is not mentioned to not use the handguard for opening and closing the protective cover.Additionally, there are no warning stickers on the instrument or the protective cover that are warning about the dangers of using the handguard as a handle.This event occurred in (b)(6).Medwatch field address - additional information of (b)(6) was also provided.

Event Description

The initial reporter stated that he was closing the lid of the cobas p 471 centrifuge unit and a piece of the protective cover broke off and fell.The reporter closed the cover using the acrylic glass handguard part of the cover instead of the cover handle.A piece of the acrylic glass handguard broke and dropped down.

Manufacturer Narrative

Evaluation result and evaluation conclusion codes have been updated.

• Brand Name: COBAS P 471 CENTRIFUGE UNIT
• Type of Device: AUTOMATED CENTRIFUGE UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9740906
• MDR Text Key: 220290588
• Report Number: 1823260-2020-00507
• Device Sequence Number: 1
• Product Code: JQP
• 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: 03/12/2020

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: P471
• Device Catalogue Number: ASKU
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1