MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-02-09 for DIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE DF306 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[37795281]
Siemens healthcare diagnostics received customer complaints for dimension sirolimus (siro) lot eb6064. The complaints were related to qc shifts and imprecision. Siemens healthcare diagnostics conducted an investigation on board stability for dimension siro lot eb6064. Investigation determined that dimension siro lot eb6064 does not meet the open well stability claim of two days. Internal testing has shown biases ranging from -82% to +123% on a pooled sample with a sirolimus concentration o 8. 7 ng/ml [9. 5 mmol/l] when tested on subsequent days of the two day open well stability period. Results are unaffected at the start of the open well stability period. Quality control is likely to catch the issue on subsequent days of the open well stability claim. Siemens healthcare diagnostics issued an urgent medical device recall communication (b)(4) dated february, 2016 instructing customers to discontinue use and discard any remaining inventory of the affected lot and to contact siemens healthcare for replacement product.
Patient Sequence No: 1, Text Type: N, H10
[37795282]
A customer complained about qc having high assay range flags and precision issues with sirolimus (siro) lot eb6064. It is unknown if patient treatment was altered or prescribed on the basis of the poor precision with siro lot eb6064. There was no report of adverse health consequences as a result of poor precision with siro lot eb6064.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00014 |
| MDR Report Key | 5419947 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-09 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2015-03-03 |
| Date Added to Maude | 2016-02-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-02/12/2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? SIROLIMUS FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION? SIRO |
| Product Code | NRP |
| Date Received | 2016-02-09 |
| Catalog Number | DF306 |
| Lot Number | EB6064 |
| Device Expiration Date | 2016-03-04 |
| 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 | 2016-02-09 |