MAUDE Adverse Event Report: BIO-RAD LABORATORIES PR4100 MICROPLATE READER US; SPECTROPHOTOMETER FOR CLINICAL USE

Catalog Number 45591587

Device Problems Nonstandard Device (1420); Smoking (1585)

Patient Problem No Information (3190)

Event Date 02/17/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 bio-rad laboratories technical support received a call from a customer stating that the d-link dub-h4 usb hub, used with the pr4100 microplate reader system, started smoking when the user turned on the pr4100 computer.The pr4100 microplate reader is a 96-well absorbance reader for the measurement of light absorbance (optical density-od) of liquid media.The instrument is intended to be used primarily for in vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states.The pr4100 system was turned off and no injury occurred.Bio-rad laboratories technical support sent the customer a tripp lite usb hub as a replacement.A field corrective action has been generated to replace all existing d-link hubs that are currently in use for pr4100 microplate reader customers.Bio-rad laboratories will submit a follow-up report upon completion of the field corrective action.

Event Description

As noted in our initial report bio-rad laboratories committed to providing a follow-up report to the fda.There has been no new or additional information, and bio-rad laboratories has completed the field action for this incident.

• Brand Name: PR4100 MICROPLATE READER US
• Type of Device: SPECTROPHOTOMETER FOR CLINICAL USE
• Manufacturer (Section D): BIO-RAD LABORATORIES; 3, boulevard raymond poincare; marnes-la-coquette, 92430 ; FR 92430
• Manufacturer (Section G): BIO-RAD LABORATORIES; 3, boulevard raymond poincare; marnes-la-coquette, 92430 ; FR 92430
• Manufacturer Contact: david bhend ; 6565 185th ave ne; redmond, WA 98052 ; 4254981758
• MDR Report Key: 7386745
• MDR Text Key: 104277531
• Report Number: 3022521-2018-00001
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 45591587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3022521-4/2/2018-002C
• Patient Sequence Number: 1