MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-09-28 for TDM CONTROL SET 04521536190 manufactured by Roche Diagnostics.
[26900281]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26900282]
A health care professional in a hospital setting alleged an injury while opening a control bottle. The user indicated the bottle was "tough" to open and injured a tendon. According to an occupational physician the user now requires surgery. It was noted that there was no damage on the control bottle which could have caused an injury. It was noted that the user has been performing horseback vaulting exercises for "two decades" which may have preconditioned her for the injury.
Patient Sequence No: 1, Text Type: D, B5
[27560600]
The customer stated the health care professional may have had a previous injury due to two decades of performing exercises on horseback. This previous injury may have caused or contributed to the health care professional requiring surgery. The control vials are a plastic dropper bottle with a screw on cap. The material is ready to use. There are no special instructions provided or needed to open the vial. The lot number of the control set was 696748 as stated in the medwatch report. The vial involved in the event was discarded. The specific lot number of the vial could not be provided by the customer. The investigation of this event did not confirm the customer's findings. No issues were found with manufacturing practices. Inspection of the lot number in question was performed. All bottles could be opened normally without application of force. It is not likely that the injury occurred due to a tightly capped bottle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04231 |
| MDR Report Key | 5108170 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-28 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-07-21 |
| Date Added to Maude | 2015-09-28 |
| 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 | 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 | TDM CONTROL SET |
| Generic Name | MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) |
| Product Code | JJY |
| Date Received | 2015-09-28 |
| Model Number | NA |
| Catalog Number | 04521536190 |
| Lot Number | 696748 |
| 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 | 2015-09-28 |