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 2017-02-06 for DIMENSION? DF119 SMN 10711991 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[66679405]
The customer contacted the siemens customer care center (ccc). The cause of the discordant amm results is unknown. The customer recalibrated the instrument with a new amm lot ea7322 and set new ranges for the qc. The customer reran the qc and the results obtained were within the expected ranges. Siemens healthcare diagnostics is conducting a recall for the dimension? Ammonia flex? Reagent cartridge/amm df119 (smn # (b)(4)) kit lots (fb7152, eb7180, ba7194, ea7223, ba7250) and dimension vista? Ammonia flex? Reagent cartridge / amm k3119 (smn #(b)(4)) kit lots (16187be, 16225bb,16265ab). Siemens healthcare diagnostics has determined that dimension amm (df119) flex reagent cartridge lots fb7152, eb7180, ba7194, ea7223, ba7250 and dimension vista amm (k3119) flex reagent cartridge flex lots 16187be, 16225bb, 16265ab do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay. These lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the 60-day claim in the instructions for use (ifu). An urgent field safety notices (ufsn's) dc17-01. A. Ous. Dm and dc 17. 01a. Ous. Dmv were sent to ous customers and an urgent medical device recalls (umdr's) dc17-01. A. Us. Dm and dc 17. 01a. Us. Dmv were sent to us customers in december 2016. The ufsn and umdr informs the customers to discontinue use of and discard the affected kit lot. The customer has stated that they received the umdr letter which was mailed after the incident occurred at their lab. Siemens recommends using an alternate lot of dimension or dimension vista amm siemens is currently investigating the root cause of this issue.
Patient Sequence No: 1, Text Type: N, H10
[66679406]
Discordant low ammonia (amm) results were obtained on qc and a patient sample on the dimension exl system. The patient result was reported to the physician who questioned the result. The qc was rerun after recalibration and higher results within laboratory ranges were obtained. The patient sample was not retested. There is no indication that patient treatment was altered or prescribed on the basis of the discordant low amm results. There are no reports of patient intervention or adverse health consequences as a result of the discordant low amm results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00056 |
| MDR Report Key | 6305852 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-06 |
| Date of Report | 2017-02-06 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2017-01-08 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-02-06 |
| 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 | 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-12/27/2016-004-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? AMM AMMONIA FLEX? REAGENT CARTRIDGE |
| Product Code | JIF |
| Date Received | 2017-02-06 |
| Catalog Number | DF119 SMN 10711991 |
| Lot Number | FB7152 |
| Device Expiration Date | 2017-06-01 |
| 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 | 2017-02-06 |