MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2012-12-04 for VITROS 250 CHEMISTRY SYSTEM 8132086 manufactured by Ortho-clinical Diagnostics.
[2984523]
The customer obtained multiple discordant vitros ckmb patient results while performing correlation studies between two vitros 250 chemistry systems. Patient 1, vitros 250 #1 result= 22 vs. Expected vitros 250 #2 result= 12 u/l. Patient 2, vitros 250 #1 result= 24 vs. Expected vitros 250 #2 result= 13 u/l and, patient 5, vitros 250 #1 result= 5 vs. Expected vitros 250 #2 result= 18 u/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action. However, the discordant vitros ckmb patient results were not reported from the laboratory. There was no allegation of harm to patients as a result of this event. This report corresponds to ortho clinical diagnostics, inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10261416]
The investigation determined that discordant vitros ckmb patient results were observed when performing patient correlation studies between two vitros 250 chemistry systems. The root cause of this event is two types of user error. Firstly, the customer did not routinely monitor vitros ckmb performance by running quality controls as per device labeling. Secondly, the customer manually entered vitros ckmb calibration parameters on vitros 250 #1 and did not verify accuracy of the calibration prior to use. Following ckmb calibration, acceptable concordance and accuracy was observed. The root cause of the event was discussed with the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319681-2012-00233 |
| MDR Report Key | 2856858 |
| Report Source | 00,01,05 |
| Date Received | 2012-12-04 |
| Date of Report | 2012-12-04 |
| Date of Event | 2012-11-05 |
| Date Mfgr Received | 2012-11-05 |
| Device Manufacturer Date | 2000-01-27 |
| Date Added to Maude | 2013-03-11 |
| 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 | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS 250 CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JLB |
| Date Received | 2012-12-04 |
| Catalog Number | 8132086 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-04 |