MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY

Model Number DIMENSION XPAND PLUS WITH HM

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: DIMENSION XPAND PLUS WITH HM
• Type of Device: CLINICAL CHEMISTRY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5673993
• MDR Text Key: 45752230
• Report Number: 1226181-2016-00290
• Device Sequence Number: 0
• Product Code: MLM
• Reporter Country Code: US
• PMA/PMN Number: K112999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND PLUS WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1