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 2018-02-16 for DIMENSION VISTA? K1023 SMN 10445160 manufactured by Siemens Healthcare Diagnostics Inc.
[100513146]
Siemens healthcare diagnostics has confirmed that dimension vista? Calcium (ca) flex? Reagent cartridge lot 17171bd may produce erroneously low results from specific well sets. If ca reagent calibration is performed using an unaffected well set and qc and patient samples are subsequently processed using an affected well set, ca results may be falsely depressed up to -2. 8 mg/dl (-0. 7 mmol/l). If ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. The observed bias for serum, plasma, and urine specimens are similar. Urgent medical device recall, vc-18-03. A. Us and urgent field safety notice vc-18-03. A. Ous dated january, 2018 were issued to customers who had been shipped dimension vista? Calcium (ca) flex? Reagent lot 17171bd. Customers were instructed to discontinue use and to discard lot 17171bd.
Patient Sequence No: 1, Text Type: N, H10
[100513147]
Discordant imprecise and out of range calcium (ca) results were obtained on quality control samples on the dimension vista 1500 instrument s/n (b)(4). The customer stated there was no impact on the patient results. There is no known report of any delays in reporting, patient intervention, or adverse health consequences due to the discordant imprecise and out of range ca qc results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00110 |
| MDR Report Key | 7278567 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-01-16 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-06-20 |
| Date Added to Maude | 2018-02-16 |
| 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 | JAMES MORGERA |
| Manufacturer Street | 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 |
| Manufacturer Street | 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 | 2517506-02/01/2018-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? CA CALCIUM FLEX? REAGENT CARTRIDGE |
| Product Code | CIC |
| Date Received | 2018-02-16 |
| Catalog Number | K1023 SMN 10445160 |
| Lot Number | 17171BD |
| Device Expiration Date | 2018-06-20 |
| 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 |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-16 |