MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-14 for COBAS AMPLIPREP INSTRUMENT N/A 03051315001 manufactured by Roche Molecular Systems, Inc..
[138854141]
Investigation revealed that the fse was not logged into the system using a service account and overruled the system by using a magnet to open the cobas ampliprep instrument's main cover, which should have been closed. In addition, service documentation (isdoc) provides safety information and several warnings in relation to moving parts and personal injury; specifically, the documentation indicates contact with moving parts may result in personal injury and damage to instrument. It is unknown why the fse had his hand inside the instrument at the moment of the accident. However, the instrument performed as expected after the fse loaded the carrier rack. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138854142]
A roche field service engineer (fse) from (b)(6) had an accident while repairing a cobas ampliprep instrument. With the instrument on, and main cover opened, the fse put his hand in the instrument after loading a carrier rack. Immediately following the placement of the carrier rack, the cobas ampliprep instrument's left transfer head crashed into his hand. The fse's finger was cut and broken. The fse went to the hospital where he received stitches and a metal splint. The fse received the following medications: coraspin, zimaks, dexday.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00011 |
| MDR Report Key | 8422427 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | ROCHE INTERNATIONAL ROTKREUZ |
| Manufacturer Street | FORRENSTRASSE 2 |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR; |
| Product Code | JJH |
| Date Received | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | 03051315001 |
| Lot Number | NA |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |