MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-01 for PRISM NEXT ANALYZER 06A36-34 manufactured by Abbott Manufacturing Inc.
[90840228]
This information was previously reported in 1415939-2017-00166, however a correction on the suspect medical device manufacturer location was identified on 1 november 2017. Customer complaint data was reviewed and no trends or related issues were identified. The prism next operations manual was reviewed and was found to contain adequate instruction for the removal and replacement of the rack plate assembly. In addition, the 2017 ul certification memo indicates abbott diagnostic equipment and accessories are certified to the appropriate us, (b)(6) and international safety standards. Abbott diagnostic division performs an in-depth risk analysis which ensures that the overall residual risk is at an acceptable level. Based on the available information, no product deficiency of the prism next analyzer 06a36-34, was identified.
Patient Sequence No: 1, Text Type: N, H10
[90840229]
While servicing the prism analyzer the abbott ambassador injured himself while lifting the sample plate assembly. He had an ultrasound performed and will be undergoing surgery on (b)(6) 2017 due to an aggravated hernia. In addition he cannot lift anything over 20 lbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00410 |
| MDR Report Key | 6995130 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-11-01 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2017-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM NEXT ANALYZER |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | MZA |
| Date Received | 2017-11-01 |
| Catalog Number | 06A36-34 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-01 |