MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGANOSTICS INC. DIMENSION XPAND PLUS W/O HM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION XPAND PLUS W/O HM

Device Problem Mechanical Problem (1384)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The customer's quality controls (qc) were out of range low for levels 1 and 2.The customer obtained a different reagent lot of cre2 (lot fb8227), and was satisfied with the results obtained with the new reagent lot.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced the syringes for reagent arm 1 (r1) and sample arm.The cse ran system check, which passed.The customer verified that the patient results and qc were recovering within acceptable limits.The cause of the discordant, falsely depressed creatinine (cre2) results on patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed creatinine (cre2) results were obtained on a dimension xpand plus w/o hm instrument.The initial results were not reported to the physician(s).The samples were sent to an alternate laboratory and were tested on an alternate instrument, resulting higher and as expected.The results obtained on the alternate instrument were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed cre2 results.

Manufacturer Narrative

Additional information (17-jan-2018): a siemens headquarters support center (hsc) specialist reviewed the event data and was unable to determine if reagent delivery or carryover issues occurred based on the result monitors without data.Hsc determined that the potential cause of the event was associated with sample and reagent arm 1 (r1) fluidics delivery, which was resolved with maintenance performed by the siemens customer service engineer (cse).Additional information (22-jan-2018): the customer indicated that quality controls and patient samples were recovering as expected and denied further investigation.The cause of the event is unknown.

• Brand Name: DIMENSION XPAND PLUS W/O HM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGANOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 7183188
• MDR Text Key: 97755151
• Report Number: 2517506-2018-00013
• Device Sequence Number: 0
• Product Code: JFY
• Combination Product (y/n): N
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/12/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND PLUS W/O HM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1