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 2018-11-08 for DIMENSION VISTA? K2038 SMN 10464356 manufactured by Siemens Healthcare Diagnostics Inc..
[128594528]
The customer contacted the siemens healthcare diagnostics customer care center (ccc) concerning an absorbance error flagged creatine kinase cki test where a below assay range result was incorrectly reported. The customer did not report issues with any other assays on the instrument. The customer stated that the cki quality control was within laboratory ranges on the date of testing. Siemens headquarters support center (hsc) has reviewed the information provided and instrument data logs and has concluded the investigation. The customer stated that they have not had any issues with any other samples. Hsc review of the data logs showed that the instrument was in good working order during the time of the discrepant cki result and did not show any instrument issues. Hsc reviewed the instrument data for cki and found sample # (b)(6) gave an e141 absorbance error for the cki result. The vista operator's guide instructs the customer that an e141 absorbance error means that the measurement exceeded the photometer's detection limit. The operator's guide also instructs the customer to check the method ifu to determine if the sample can be diluted and, if so, to make the smallest dilution possible to bring the result down into the assay range. The vista cki method can be diluted. The vista cki method has built in auto dilutions of 1:7 and 1:14. According to the information provided by the customer to siemens ccc, the customer stated cki was an add-on test and that the initial cki result was insufficient. The customer then reprocessed the sample for cki separate from the other tests ordered on the sample and received an absorbance error. The customer reprocessed the sample on another vista instrument ((b)(4)) and received an absorbance error. The customer then diluted the same sample from the original vista instrument and processed the diluted sample as id (b)(6) with a 1:7 auto dilution and received a result of 2961 (u/l). The instrument data files did identify the customer runs described. The vista instrument reported all information correctly and at no point did the sample # (b)(6) result a value below assay range. The cause of the discordant cki result is use error. Hsc concluded that the vista instrument and cki reagent is functioning as intended. There is no evidence of a product nonconformance. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[128594669]
A discordant, below assay range, creatine kinase (cki) result was reported for a patient sample from a dimension vista 1500 system. The result was provided to the physician. The same sample was reprocessed the same day with a dilution and a higher, correct result was obtained. A corrected report was issued. No treatment was provided to the patient on the basis of the reported discordant cki result. There are no known reports of patient intervention or adverse health consequences due to the discordant cki result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00628 |
| MDR Report Key | 8053079 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2018-11-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? CKI CREATINE KINASE FLEX? REAGENT CARTRIDGE |
| Product Code | CGS |
| Date Received | 2018-11-08 |
| Catalog Number | K2038 SMN 10464356 |
| Lot Number | 18100BE |
| Device Expiration Date | 2019-04-10 |
| 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 | 2018-11-08 |