MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-21 for DIMENSION? TACROLIMUS FLEX? REAGENT CARTRIDGE DF207 (SMN # 10700795) manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[73672608]
Siemens healthcare diagnostics has determined that the cause of the erroneously low tac result was use error. The following are test steps in the tac instructions for use under patient samples: - transfer 200 ul to a sample cup or ssc (small sample container) for processing on the instrument - select mode: limited cup, no level sense of ssc as appropriate - select fluid type: csf/blood. In addition, the ifu states: do not process primary tubes directly on the dimension for this assay. The customer neglected to pour the sample into a sample cup or small sample container the instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[73672609]
The customer processed an infant patient sample on the dimension xpand system for the tacrolimus (tac) method using an edta whole blood collection tube instead of using a sample cup or small sample container (ssc) as described in the tac instructions for use. A result less than the analytical measurement range (< 1 ng/ml) was obtained and reported. The physician increased the dose of tacrolimus for the infant patient based on the falsely low tacrolimus results on (b)(6) 2017. It was stated that another clinical lab operator noticed the original operator neglected to use ssc cups. The same sample was repeated on the same instrument using a ssc as instructed in the instructions for use (ifu) for the method. A higher result was obtained and a corrected report was issued on (b)(6) 2017. There are no reports of adverse health consequences due to the initially low tac result or the increased dose of tacrolimus. Additional information was received on april 6, 2017 and it was stated that there was no bad influence on the patient's health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00357 |
| MDR Report Key | 6511328 |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-11-14 |
| Date Added to Maude | 2017-04-21 |
| 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 500 GBC DRIVE 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 PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION? TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION? TAC |
| Product Code | MLM |
| Date Received | 2017-04-21 |
| Catalog Number | DF207 (SMN # 10700795) |
| Lot Number | GB7318 |
| Device Expiration Date | 2017-11-14 |
| Operator | HEALTH PROFESSIONAL |
| 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 PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-21 |