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 2016-05-23 for DIMENSION XPAND PLUS WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[45752230]
The customer contacted the siemens customer care center (ccc). The customer stated that qc was within limits on the morning of the event. A discordant tacrolimus (tacr) result was obtained, after which qc was run, resulting out of range. The customer performed troubleshooting and reran qc, which resulted within range. However, after patient samples were repeated, qc resulted out of range on all three levels. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse found a leak on the sample probe drain tubing. The cse clipped the sample probe tubing and reconnected it. The cse adjusted the cuvette film cartridge on the left side of the instrument compartment because it was too low. The cse performed all alignments on reagent probe 1 (r1), reagent probe 2 (r2) and photometer, all of which were acceptable. The cse rearranged the cuvettes as they were not lying properly against the window as indicated, and turned up heated air. The cse noticed that the customer was running qc on whole blood, and the type of sample cup was changed from "no limited level sense" to small sample container cup (ssc). The cse changed the settings back to "limit level sense" and ran qc, resulting within range. The cause of the discordant, falsely low tacrolimus result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[45752231]
A discordant, falsely low tacrolimus (tacr) result was obtained on a dimension xpand plus with hm instrument for one patient sample that was receiving treatment. The initial result was reported to the physician(s), who questioned it. The customer stated that the nurses called the laboratory and stated the results were low on patients that were receiving treatment, and results were expected to be higher. The customer ran quality controls and results were out of range. The customer replaced the reagent probe and performed alignments, after which a system check passed. The customer then recalibrated with a different reagent lot and reran qc, which resulted within range. The sample was repeated on the same instrument after recalibration, resulting higher. The sample was sent out to another facility for testing. The customer stated the results from that facility were not different enough to file a corrected report. The result obtained on the new lot was also not reported to the physician(s). No corrected report was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low tacrolimus result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00290 |
| MDR Report Key | 5673993 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-04-28 |
| Device Manufacturer Date | 2004-04-30 |
| Date Added to Maude | 2016-05-23 |
| 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 | MS. 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 |
| 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 XPAND PLUS WITH HM |
| Generic Name | CLINICAL CHEMISTRY |
| Product Code | MLM |
| Date Received | 2016-05-23 |
| Model Number | DIMENSION XPAND PLUS WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |