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 2018-03-07 for CALIBRATOR CLINICAL CHEMISTRY 11183982216 manufactured by Roche Diagnostics.
[101769147]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[101769148]
A customer complained that a laboratory staff member had cut her thumb when trying to open a ion selective electrode (ise) standard high ampule. The customer cut her right thumb by accident. The customer was given a prescription and an application of bactroban ointment to the injured site. The customer also received a tetanus shot. The customer returned to work following the treatment. The ise standard high ampule was not previously opened. Product labeling for the ise standard high states "wear protective glasses when handling the ampule. Using a piece of gauze or other protective material, carefully snap the top off the ampule. " the only piece of personal protective equipment that the customer was known to be wearing were plastic gloves. Further clarification was requested in regards to if the customer was following the proper handling instructions, but no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[109124331]
Since it was unknown if the customer followed the handling instructions in the package insert, the investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00687 |
| MDR Report Key | 7320545 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-07 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-02-15 |
| Date Added to Maude | 2018-03-07 |
| 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 | CALIBRATOR CLINICAL CHEMISTRY |
| Generic Name | ISE STANDARD HIGH |
| Product Code | JIX |
| Date Received | 2018-03-07 |
| Model Number | NA |
| Catalog Number | 11183982216 |
| Lot Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-07 |