MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-11 for VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382 manufactured by Ortho-clinical Diagnostics.
[16465565]
The customer complained that higher than expected vitros crbm results were obtained from a single level of vitros tdm fluid tested on a 5600 integrated system. Tdm pv l3673: 17. 53, 17. 76, 17. 60 and 17. 49 ug/ml vs expected 13. 32 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action. The customer made no indication that patient samples were affected, however, the investigation could not rule out that patient samples were not affected, or would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number four of four mdr? S for this event. Four 3500a forms are being submitted for this event as four devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16694780]
The investigation determined that higher than expected vitros crbm results were obtained from a single level of vitros tdm fluid tested on a 5600 integrated system. The assignable cause of the event is unknown; however, an unexpected instrument issue or user error due to inappropriate pre-analytical sample handling cannot be ruled out as contributing factors. There was no indication the vitros crbm micro slide malfunctioned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319809-2015-00031 |
| MDR Report Key | 4590647 |
| Report Source | 05 |
| Date Received | 2015-03-11 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-02-16 |
| Date Mfgr Received | 2015-02-16 |
| Device Manufacturer Date | 2014-11-13 |
| Date Added to Maude | 2015-04-15 |
| 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 CRBM SLIDES |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | KLT |
| Date Received | 2015-03-11 |
| Catalog Number | 8892382 |
| Lot Number | 3924-0085-8851 |
| Device Expiration Date | 2015-07-01 |
| 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 | 2015-03-11 |