ORTHO VISION ANALYZER ID-MTS
Report
- Report Number
- 0001319681-2022-00602
- Event Type
- Injury
- Date Received
- November 18, 2022
- Date of Event
- November 7, 2022
- Report Date
- November 22, 2022
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- KSZ
- UDI-DI
- 10758750012817
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN ORTHO LABORATORY SPECIALIST OBTAINED MULTIPLE FRACTURES IN THEIR BIG TOE DUE TO THE NOISE ENCLOSURE FALLING ON THEIR FOOT DURING REMOVAL. THE ORTHO LABORATORY SPECIALIST RECEIVED MEDICAL ATTENTION. ORTHO MEDICAL SAFETY OFFICER ASSESSED THE INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED PERSON.
FOLLOW-UP REPORTED CREATED SINCE INCORRECT MANUFACTURING SITE NUMBER WAS USED IN INITIAL REPORT (1319681-2022-00602). NUMBER SHOULD HAVE BEEN FROM RARITAN# (B)(4). AN ORTHO LABORATORY SPECIALIST OBTAINED MULTIPLE FRACTURES IN THEIR BIG TOE DUE TO THE NOISE ENCLOSURE FALLING ON THEIR FOOT DURING REMOVAL. THE ORTHO LABORATORY SPECIALIST RECEIVED MEDICAL ATTENTION. ORTHO MEDICAL SAFETY OFFICER ASSESSED THE INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED PERSON.
THE REPORTED INCIDENT OCCURRED AT THE MEDLABWAHL LABORATORY IN LUDENSCHEID, GERMANY WHEN THE NOISE ENCLOSURE FROM THE ORTHO BIOVUE VISION ANALYZER FELL OFF OF A TRANSPORT CART ONTO THE FOOT OF AN ORTHO LAB SPECIALIST WHO HAPPENED TO BE OPENING A DOOR FOR THE ORTHO FIELD ENGINEER TO GET THROUGH WITH HIS CART. FOR REPORTING PURPOSES AND WITH THE INFORMATION KNOWN AT THAT TIME, ORTHO CONSIDERED THE ORTHO BIOVUE VISION ANALYZER TO BE A SIMILAR PRODUCT TO THE FDA CLEARED ORTHO ID-MTS VISION ANALYZER AND THEREFORE, THE EVENT WAS REPORTED TO THE FDA. ORTHO¿S FURTHER INVESTIGATION INTO THIS EVENT HAS FOUND THAT THE NOISE ENCLOSURE (THAT CAUSED THE REPORTED INJURY) IS NOT AVAILABLE FOR THE FDA CLEARED ORTHO ID-MTS VISION OR ORTHO ID-MTS VISION MAX¿ ANALYZERS AND THEREFORE, THIS EVENT WAS REPORTED IN ERROR.
AN ORTHO LABORATORY SPECIALIST OBTAINED MULTIPLE FRACTURES IN THEIR BIG TOE DUE TO THE NOISE ENCLOSURE FALLING ON THEIR FOOT DURING REMOVAL. THE ORTHO LABORATORY SPECIALIST RECEIVED MEDICAL ATTENTION. ORTHO MEDICAL SAFETY OFFICER ASSESSED THE INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED PERSON. MXP#: (B)(4), CE#: (B)(4).
AN ORTHO LABORATORY SPECIALIST OBTAINED MULTIPLE FRACTURES IN THEIR BIG TOE DUE TO THE NOISE ENCLOSURE FALLING ON THEIR FOOT DURING REMOVAL. THE ORTHO LABORATORY SPECIALIST RECEIVED MEDICAL ATTENTION. ORTHO MEDICAL SAFETY OFFICER ASSESSED THE INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED PERSON. MXP# (B)(4) CE# (B)(4).
AN ORTHO LABORATORY SPECIALIST OBTAINED MULTIPLE FRACTURES IN THEIR BIG TOE DUE TO THE NOISE ENCLOSURE FALLING ON THEIR FOOT DURING REMOVAL. THE ORTHO LABORATORY SPECIALIST RECEIVED MEDICAL ATTENTION. ORTHO MEDICAL SAFETY OFFICER ASSESSED THE INJURY AS SERIOUS. THERE IS NO CHANGE IN THE HEALTH OF THE INJURED PERSON. MXP# 32191146 CE# 0000087
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231962 | ORTHO VISION ANALYZER ID-MTS | AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM | KSZ | ORTHO-CLINICAL DIAGNOSTICS, INC. | 6904577 | 10758750012817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |