MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-01-17 for AUTO-TROL PLUS B LEVEL 1 03321169001 manufactured by Roche Diagnostics.
[4165663]
The customer alleged there was an injury during maintenance activities on their b221 analyzer. The customer stated that when removing the glass quality control vials to dispose of them, the first finger on the right hand was injured by the glass vial. The customer was immediately admitted to the aed. The doctor checked the finger and found three small pieces of glass inside the finger. The doctor removed the glass and the wound was dressed. The customer was given a tetanus toxoid vaccine. The customer returned to the laboratory and continued his duties. The customer was wearing a laboratory coat and disposable plastic gloves at the time of the incident. The customer was back to work and in good condition.
Patient Sequence No: 1, Text Type: D, B5
[11420653]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[11667901]
It was determined the customer did not follow the operator's manual for safely removing the glass ampules from the holding rack during disposal. The injury would not have occurred if procedures had been followed. Product was returned by the customer for investigation. Both the returned product and six retention lots were investigated. Two instances of a glass pick on the side of the ampoule dome head were found and one ampoule had a shard of glass adhering to the side of the ampoule halfway down the bulb. The device history records for the complaint lot as well as lots manufactured in the same month were examined. Incoming inspection records of raw ampules used in the manufacture of the lots were also examined. Equipment log books and preventative maintenance schedules were reviewed for the ampule filling equipment. Training records for ampoule filling technicians were confirmed and interviews were conducted with manufacturing and quality control personnel. The root cause of the glass picks found was attributed to human error as the manufacturing and packaging personnel failed to detect and remove the defective ampoules.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-00347 |
| MDR Report Key | 3581262 |
| Report Source | 01,05,06 |
| Date Received | 2014-01-17 |
| Date of Report | 2014-03-18 |
| Date of Event | 2013-12-23 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-01-17 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO-TROL PLUS B LEVEL 1 |
| Generic Name | MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)21 |
| Product Code | JJY |
| Date Received | 2014-01-17 |
| Model Number | NA |
| Catalog Number | 03321169001 |
| Lot Number | 21430735 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-17 |