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 2014-11-04 for VITROS CHEMISTRY PRODUCTS CKMB SLIDES 8001133 manufactured by Ortho-clinical Diagnostics.
[5072009]
The customer reported lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system. Vitros ckmb qc result = 13. 9, 13. 0, 7. 0 u/l vs expected result of 20. 1 u/l. A biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected. No patient samples were tested during this time period. There was no allegation of patient harm as a result of this event. This report is number three of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12548561]
The investigation determined that lower than expected vitros ckmb quality control results were obtained on a vitros 250 chemistry system. After recalibrating the same vitros ckmb reagent lot, acceptable quality control performance was observed using a fresh quality control sample. The investigation concludes that the most likely cause of this event is a suboptimal calibration issue. The cause of the suboptimal calibration is unknown. An instrument issue, reagent issue or a fluid issue could not be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2014-00056 |
| MDR Report Key | 4224634 |
| Report Source | 00,01,05 |
| Date Received | 2014-11-04 |
| Date of Report | 2014-11-04 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2013-11-04 |
| Date Added to Maude | 2014-11-18 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 513 TECHNOLOGY BLVD. |
| Manufacturer City | ROCHESTER NY 14652 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14652 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS CKMB SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JHS |
| Date Received | 2014-11-04 |
| Catalog Number | 8001133 |
| Lot Number | 4932-0191-8710 |
| Device Expiration Date | 2015-05-01 |
| 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 | 2014-11-04 |