MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for VITROS 5600 INTEGRATED SYSTEM 6802413 manufactured by Ortho-clinical Diagnostics.
[49786461]
The investigation determined that there was a discrepancy in the units of measure for vitros afp results between a customer? S vitros 5600 integrated system and laboratory information system (lis) the assignable cause of these events was determined to be user error. The vitros 5600 integrated system was not correctly configured by the operator to report vitros afp results with units ng/ml, as per the configuration of the afp assay in the lis. Once the vitros 5600 integrated system and the lis were configured in the same units of measure, afp results with the expected unit of measure were obtained. The vitros 5600 integrated system performed as per its configuration. No malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[49786466]
A customer identified a discrepancy in the measuring units between their vitros 5600 integrated system and laboratory information system (lis). Vitros afp patient results obtained were displayed with measuring units of iu/ml on the customer's vitros 5600 integrated system, while the same results were displayed with measuring units of ng/ml on the laboratory information system (lis). Therefore, the vitros afp results for 36 different patients were ~1. 4 times lower than expected due to the discrepancy in the unit of measure on the vitros (iu/ml) versus the lis (ng/ml). Results with the incorrect units of measure may lead to inappropriate physician action if they were to occur undetected on patient samples. Results with incorrect units were reported from the laboratory, however corrected reports were issued. There was no allegation of patient harm as a result of the events. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2016-00160 |
| MDR Report Key | 5777199 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2016-06-08 |
| Device Manufacturer Date | 2016-03-08 |
| Date Added to Maude | 2016-07-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 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 | 0 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | CDZ |
| Date Received | 2016-07-07 |
| Catalog Number | 6802413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Brand Name | VITROS 5600 INTEGRATED SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-07-07 |
| Catalog Number | 6802413 |
| 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 | 2016-07-07 |