MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for PR4100 MICROPLATE READER US 45591587 manufactured by Bio-rad Laboratories.
[104277510]
Patient Sequence No: 1, Text Type: N, H10
[104277531]
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.
Patient Sequence No: 1, Text Type: D, B5
[131389927]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2018-00001 |
| MDR Report Key | 7386745 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-02-17 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID BHEND |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981758 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 3, BOULEVARD RAYMOND POINCARE |
| Manufacturer City | MARNES-LA-COQUETTE, 92430 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3022521-4/2/2018-002C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PR4100 MICROPLATE READER US |
| Generic Name | SPECTROPHOTOMETER FOR CLINICAL USE |
| Product Code | JJQ |
| Date Received | 2018-03-30 |
| Returned To Mfg | 2018-02-27 |
| Catalog Number | 45591587 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 3, BOULEVARD RAYMOND POINCARE MARNES-LA-COQUETTE, 92430 FR 92430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-30 |