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 2017-03-30 for DIMENSION VISTA? FERRITIN FLEX? REAGENT CARTRIDGE K6440 (SMN 10445136) manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[71335073]
Siemens healthcare diagnostics has determined that dimension troponin (tni) and dimension vista digoxin (digxn), estradiol (e2), ferritin (ferr), prolactin (prl), and thyroid stimulating hormone (tsh) have incorrect units for botin in the instructions for use and incorrectly state the level at which biotin does not interfere. In the cases of tni, e2, ferr, prl, and tsh, there is a significant interference at the levels incorrectly stated in the current ifus. Since the biotin si units are listed as umol/l instead of nmol/l the si units are incorrect by a factor of 1000 higher than the level at which biotin does not interfere, e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. Digxn si units for biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current ifu. Siemens issued an urgent medical device correction (udmc), dated march 29, 2017, communication (b)(4), to all us accounts and an urgent field safety notice (ufsn), dated march 2017, communication (b)(4), to all outside us accounts who had been shipped the impacted products. Customers were instructed that the non-interfering table for biotin in the letter supersedes the information related to this section in the current ifus for the assays listed until the ifus are updated.
Patient Sequence No: 1, Text Type: N, H10
[71335074]
Customer reported that there is a typographical error in the dimension vista free thyroxine (ft4) for biotin in the non-interfering table of the instructions for use. Customer is comparing biotin syst? Me international d'unit? S [si units] for ft4 which are nmol/l to ferritin (ferr) and thyroid stimulating hormone (tsh) which are in umol/l. However, ft4 si units are correct and the biotin si units for ferr and tsh should be nmol/l. There are no reports of patient intervention or adverse health consequences due to the incorrect si units for biotin in ferr ifu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00299 |
| MDR Report Key | 6445792 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-09-27 |
| Date Added to Maude | 2017-03-30 |
| 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 | PH.D EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| 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 PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-03/30/2017-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? FERRITIN FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION VISTA? FERR |
| Product Code | CEC |
| Date Received | 2017-03-30 |
| Catalog Number | K6440 (SMN 10445136) |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 |
| Brand Name | DIMENSION VISTA? FERRITIN FLEX? REAGENT CARTRIDGE |
| Generic Name | DIMENSION VISTA? FERR |
| Product Code | JMG |
| Date Received | 2017-03-30 |
| Catalog Number | K6440 (SMN 10445136) |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-30 |