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 2014-03-07 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[4320731]
The customer observed non-reproducible vitros crbm quality control and patient results that were obtained when processed on a vitros 5,1fs chemistry system. Quality control: 26. 3? Mol/l vs. Expected mean 57. 0? Mol/l. Patient 1: 45. 0? Mol/l vs. 72. 7? Mol/l. Patient 2: 19. 0? Mol/l vs. 52. 7? Mol/l. The investigation was unable to reach a definitive conclusion as to which of the results were consistent with the expected values for each patient. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The initial vitros crbm patient results were reported from the laboratory; however, the physician was notified following repeat testing of the samples. There was no allegation of patient harm resulting from the action taken. 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. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11702916]
The investigation determined that non-reproducible vitros crbm quality control and patient results were obtained on vitros 5,1fs chemistry system. Precision testing using vitros phyt slides demonstrated that the vitros 5,1fs chemistry system was performing as expected at the time of the event. The customer calibrated an alternate lot of vitros crbm slides and acceptable performance was observed. The investigation was unable to determine a definitive root cause. However, the event is most likely reagent related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2014-00015 |
| MDR Report Key | 3667076 |
| Report Source | 00,01,05 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-02-06 |
| Date Mfgr Received | 2014-02-06 |
| Device Manufacturer Date | 2013-08-18 |
| Date Added to Maude | 2014-05-14 |
| 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 | BIOMEDICAL ENGINEER |
| 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 CRBM SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | KLT |
| Date Received | 2014-03-07 |
| Catalog Number | 8892382 |
| Lot Number | 3919-0079-6628 |
| Device Expiration Date | 2015-04-01 |
| 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 | 2014-03-07 |