MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-04 for PRISM NEXT ANALYZER 06A36-11 manufactured by Abbott Manufacturing Inc.
[93684431]
A review of the product labeling concluded that the issue is sufficiently addressed. The abbott prismnext operations manual warns of potential biohazards and instructs on the use of gloves, lab coats and protective eye wear when handling human-sourced material or contaminated instrument components. A review for similar complaints was performed from (b)(6) 2011, and no other complaints for the issue were found. Over the 77-month review period, the current complaint is the sole complaint for a splash in the eye with control material against the prism instrument. Additionally, a review of the prism product monitoring review did not identify any trends or related issues. Further, no related nonconformities were found against the prism instrument. Based on the information within the complaint record, the splash in the eye was due to use error as the customer was not wearing protective eye wear as instructed per the abbott prismnext operations manual while in close proximity to dispensing of control material. In summary, this investigation does not indicate any systemic issues pertaining to the abbott prism instrument; no product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[93684432]
The account stated an employee's eye was splashed with a02 control. The operator was preparing validation samples by injecting a02 control into tubes to be placed on the prism analyzer. A technician was standing close by and got splashed in the eye. The technician was not wearing eye protection and rinsed eyes for 15 minutes. The technician is preventatively taking dolutegravir and emitricitabine -tenofovir and is doing ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00511 |
| MDR Report Key | 7081819 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-09 |
| Date Mfgr Received | 2017-11-09 |
| Device Manufacturer Date | 2017-05-25 |
| Date Added to Maude | 2017-12-04 |
| 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 | 2017-12-04 |
| Catalog Number | 06A36-11 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-12-04 |