MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-21 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[5816267]
The customer reported that higher than expected crbm, lac and phyt results were obtained from multiple investigational-only samples when using vitros chemistry products crmb, lac and phyt reagents on a vitros 5,1 fs instrument. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action. Patient results were not affected; however, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of these events. This report is number one of twelve mdr? S for this event. Twelve 3500a forms are being submitted for this event as twelve devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13396298]
The investigation determined that higher than expected crbm, lac and phyt results were obtained from multiple investigational-only samples when using vitros chemistry products crmb, lac and phyt reagents on a vitros 5,1 fs instrument. The assignable cause of the events is most likely related to the n-acetyl cysteine (nac) that was added to the samples, and interferes with the vitros crbm, lac and phyt micro slide assays. The investigation is ongoing. A vitros micro slide issue cannot be ruled out for any of the affected assays; however, the investigation was able to rule out an unexpected vitros 5,1 fs system malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2015-00083 |
| MDR Report Key | 4787349 |
| Report Source | 05 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-04-22 |
| Date Mfgr Received | 2015-04-22 |
| Device Manufacturer Date | 2015-03-07 |
| Date Added to Maude | 2015-06-22 |
| 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. 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 | 2015-05-21 |
| Catalog Number | 8892382 |
| Lot Number | 3928-0087-2027 |
| Device Expiration Date | 2015-11-01 |
| 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 | 2015-05-21 |