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 2016-04-26 for DIMENSION VISTA? SYSTEM K5088 SMN10445110 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[43609661]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated actm results is user error. The account failed to input the correct level 1 calibrator value for the low level calibrator. When calibrating the method, they had incorrectly entered 0. 316 mmol/l for the zero level calibrator. The error was corrected by recalibration using correct calibrator values. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[43609662]
Falsely elevated acetaminophen (actm) results were obtained on an individual patient's samples over multiple successive samples. The results were reported to the physician who eventually questioned the results. The samples were repeated on an alternate roche cobas instrument (alternate methodology) and negative results were obtained. Patient treatment was altered on the basis of the elevated actm results. N-acetyl cysteine (nac) treatment was initiated. Results were questioned after no decrease in the actm level was seen after nac treatment. There was no report of adverse health consequences as a result of the falsely elevated actm results or the nac treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00231 |
| MDR Report Key | 5607426 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-06 |
| Date of Event | 2016-04-05 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-06-19 |
| Date Added to Maude | 2016-04-26 |
| 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 VISTA? SYSTEM |
| Generic Name | ACETAMINOPHEN FLEX? REAGENT CARTRIDGE |
| Product Code | LDP |
| Date Received | 2016-04-26 |
| Catalog Number | K5088 SMN10445110 |
| Lot Number | 15170BB |
| Device Expiration Date | 2016-06-18 |
| 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 | 2016-04-26 |