MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for DIMENSION VISTA? K7030 SMN 10445892 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[69004409]
Original mdr 9610806-2017-00035 was filed 3/1/2017. Supplement filed to correct entry in which had incorrectly been entered as 2/28/2017.
Patient Sequence No: 1, Text Type: N, H10
[69021184]
The customer contacted the siemens customer care center with an inquiry on biased low cerulplasmin results over a period of time. The described incident affects an unknown number of patient samples and the clinical context of the samples is unknown. Per the dimension vista instructions for use, measurements of ceruloplasmin are intended as an aid in the diagnosis of copper metabolism disorders. Ceruloplasmin is the main transport protein for copper in the blood. In wilson's disease and menke's syndrome, the serum ceruloplasmin are markedly diminished. Low levels of cruloplasmin also occur in patients with hepatic insufficiency and protein loss syndrome. Therefore, pathological ceruloplasmin results should trigger further non-invasive tests (e. G. Liver blood-based biomarkers) before performing liver biopsies. However, internal investigation on lot performance has been initiated and is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[69021185]
The customer notified siemens of discordant low results for ceruloplasmin (cer) on patient samples on the dimension vista 1500 international instrument over a period of time. They regarded recent results as not in concordance with the presence of iron deposits in biopsies or wilson disease diagnostics by genetic study. The hepatology unit in the hospital reviewed annual mean patient results on the dimension vista from 2014 to the present. They stated that they observed a progressive increase in the percentage of patient results <20 mg/dl that can't be explained by variations in patients attended to at the hospital or modifications in protocols. Using the cer flex reagent cartridges, the customer complains about an increase of pathologically low patient results. The cutoff of 20 mg/dl is commonly used for diagnostics of wilson disease and menke's syndrome. The cer flex reagent instructions for use shows a reference range of 20 - 60 mg/dl. This customer is observing around 38% of patients with results <20 mg/dl. Furthermore, the customer stated that he may have sent patients for unnecessary biopsies. Further investigations emerged that some patients do not have related disease. There was no report of adverse health consequences as a result of the discordant low cer results or biopsies.
Patient Sequence No: 1, Text Type: D, B5
[80526538]
Original mdr 9610806-2017-00035 was filed 3/1/2017. Mdr 9610806-2017-00035 supplement 1 was filed 3/1/2017 (supplement filed to correct entry in report date which had incorrectly been entered as 2/28/2017). Siemens healthineers headquarters support center (hsc) completed an investigation of the issue. Within the investigations, a deviation in the value assignment of the affected standard of dimension vista prot1 cal and prot1 con l /con m / con h control lots used with the dimension vista ceruloplasmin (cer) flex reagent cartridge was identified. This is leading to lower results compared to correctly assigned standards. An urgent medical device correction has been implemented advising customers to use corrected assigned values and/or acceptance ranges for the affected lots of calibrators and controls. Urgent medical device correction br-04017-ous dated may 2017 and urgent medical device correction pp-17-012. A. Us communications dated may 23, 2017 were mailed to customers who had been shipped the ceruloplasmin (cer) flex reagent cartridge. Siemens healthineers has assigned correct values to the impacted lots of calibrators and controls where sufficient material was available for a new value assignment. These lots of calibrators and controls can be used for determination of ceruloplasmin with the revised assigned values and acceptance ranges. Customers were instructed to not use the impacted lots of prot1 cal and prot1 con l /con m / con h control for cer where no corrected target values and acceptance ranges were provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610806-2017-00035 |
| MDR Report Key | 6368487 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-03-01 |
| 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 | 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 PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 9610806-05-25-2017-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? CER CERULOPLASMIN FLEX? REAGENT CARTRIDGE |
| Product Code | CHN |
| Date Received | 2017-03-01 |
| Catalog Number | K7030 SMN 10445892 |
| Lot Number | 16264MA |
| Device Expiration Date | 2017-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-01 |