MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-09-21 for DIMENSION RXL MAX WITH HM INSTRUMENT manufactured by Siemens Healthcare Diagnostics Inc.
[55318209]
The customer contacted the siemens customer care center (ccc). Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[55318210]
A discordant, falsely low methotrexate result was obtained on one patient sample on a dimension rxl max with hm instrument. Sample id (b)(6) was collected and tested on (b)(6) 2016, resulting above assay range multiple times on the same instrument. The sample was diluted, obtaining a result of 19. 07 umol/l. The sample was repeated again, and the test was aborted. The customer detected the reagent was empty, prepared a new reagent and ran quality controls, which resulted in range. The customer tested the sample again on the same instrument with a 1:6 and 1:36 dilutions, resulting below assay range. The customer repeated the sample with a 1:36 dilution, obtaining a falsely low result. The customer reported the falsely low result to the physician(s). The following day, a new sample was collected from the patient id (b)(6) and was tested on the same instrument, resulting higher than the low result reported. The results were reported to the physician(s). The physician questioned the results reported, as they did not match the clinical picture and dose of drug used. The patient showed signs of intoxication. The physician requested a rerun. The samples were repeated on the same instrument, resulting higher than the falsely low result. The results were reported to the physician, and the physician then reduced the dose of the drug administered to the patient, based on the higher repeat results. It is unknown which drug was administered. A new sample was collected from the patient and tested on the same instrument, resulting lower and in accordance with the clinical status of the patient. The results were reported to the physician(s). There are no reports of adverse health consequences due to the discordant methotrexate result.
Patient Sequence No: 1, Text Type: D, B5
[58730219]
The initial mdr 1226181-2016-00459 was filed on september 21st, 2016. Additional information (10/06/2016): a siemens headquarter support center (hsc) specialist evaluated the event data. Quality controls results on the day of event were within acceptable limits for each level. Hsc reviewed the methotrexate method parameters, and confirmed that the sample size and calculation was correct. The assay's range upper limit, which should be listed as 1. 5 umol/l, was improperly set to 2. 0 umol/l, denoting non-standard use. Hsc did not find evidence of a system malfunction. Hsc did note that data indicated a possible need to clean windows and/or address the source lamp. Hsc was unable to conclude the cause of event. Hsc does advise that the user-defined settings and assay range be configured to remain in accordance with those parameters that were validated by siemens. There have been no similar reports from this customer and this event is deemed an isolated occurrence. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2016-00459 |
| MDR Report Key | 5968209 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-09-21 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-08-24 |
| Date Mfgr Received | 2016-10-06 |
| Device Manufacturer Date | 2000-01-15 |
| Date Added to Maude | 2016-09-21 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION RXL MAX WITH HM INSTRUMENT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LAO |
| Date Received | 2016-09-21 |
| Model Number | DIMENSION RXL MAX WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Brand Name | DIMENSION RXL MAX WITH HM INSTRUMENT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-09-21 |
| Model Number | DIMENSION RXL MAX WITH HM |
| 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 INC |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |