MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-24 for DIMENSION VISTA? K6464 SMN 10461743 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[58606266]
Analysis of the instrument and instrument data indicates that the cause for the falsely elevated prog result is unknown. The prog flex reagent cartridge instructions for use limitations of procedure section states: patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58606267]
Discrepant elevated progesterone (prog) results (initial and repeat) were obtained on a patient sample on the dimension vista instrument. The result was reported to the physician who questioned the result. The same sample was later repeated at an alternate laboratory on an alternate non-siemens methodology and a lower result was obtained and reported. There is no indication that patient treatment was altered or prescribed on the basis of the discrepant elevated progesterone (prog) result. There was no report of adverse health consequences as a result of the discrepant elevated progesterone (prog) result.
Patient Sequence No: 1, Text Type: D, B5
[65922482]
Siemens healthcare diagnostics headquarters requested more information from the account to assist in the investigation. The account provided heterophile antibody blocking tube (hbt) data. After hbt tube treatment, the sample result was almost the same = 5. 28 ng/ml as the original values (first result at 9:33 am = 5. 54 ng/ml) ; 2nd result at 11:29 = 5. 42 ng/ml ; 3rd result at 11:30 = 5. 50ng/ml). The account did not provide a list of any medications that the patient may have been taking, and if they were undergoing in vitro fertilization therapy. No other tests were repeated on an alternate methodology. The customer has stopped using the prog fertility test and has not agreed to provide further information. The siemens headquarters support center investigation has been concluded as no further information is forthcoming from the account. Root cause of the incident on the single patient remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2016-00382 |
| MDR Report Key | 6052614 |
| Date Received | 2016-10-24 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-09-29 |
| Date Mfgr Received | 2016-12-12 |
| Device Manufacturer Date | 2016-06-26 |
| Date Added to Maude | 2016-10-24 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? PROGESTERONE FLEX? REAGENT CARTRIDGE |
| Product Code | JLS |
| Date Received | 2016-10-24 |
| Catalog Number | K6464 SMN 10461743 |
| Lot Number | 16179BA |
| Device Expiration Date | 2016-12-24 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| 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 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-24 |