MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-15 for DIMENSION? CLINICAL CHEMISTRY SYSTEM DF207 SMN10700795 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[47497963]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated tac sample result is unknown. Evaluation of instrument filter data by siemens headquarters support center data revealed differences in the hemoglobin concentration of the patient sample between initial and repeat runs. When the hemoglobin concentration changes the tacrolimus value changes. The most common cause for changes in hemoglobin concentration between replicates is settling of red blood cells caused by a delay in aliquoting the sample after mixing of the primary sample container has stopped. A sample handling issue specific to the individual patient who had an elevated erythrocyte sedimentation rate cannot be excluded. No sample was returned to siemens for further evaluation of the individual patient's sample. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[47497964]
A falsely elevated tacrolimus (tac) result was obtained on a patient sample on the dimension exl instrument. The patient result was reported to the physician who questioned the result. The sample was repeated on an alternate exl instrument and a lower result was obtained. A corrected report was issued. Patient treatment was not altered or prescribed on the basis of the falsely elevated tacrolimus (tac) result. There was no report of adverse health consequences to the patient due to the falsely elevated tacrolimus (tac) result..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00252 |
| MDR Report Key | 5727168 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-05-22 |
| Date Mfgr Received | 2016-05-26 |
| Device Manufacturer Date | 2015-07-05 |
| Date Added to Maude | 2016-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2016-06-15 |
| Catalog Number | DF207 SMN10700795 |
| Lot Number | GC6300 |
| Device Expiration Date | 2016-10-26 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-15 |