MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.No instrument errors occurred at the time of the event and there were no other reports of other discordant patient results.Siemens reviewed the system settings and found that the sample tube type was set for standard sample tube.The customer used a bd 1.8 ml blood collection tube for the affected patient sample.According to the sysmex cs-5100 instructions for use (ifu) section 1.4.9, usable sample tubes, the bd 1.8 ml tube cannot be used with the standard sample tube setting and in micro-sample mode, as all sample tubes must have an inner diameter larger than 9.4 mm.The inner diameter of the bd 1.8 ml tube is less than 8 mm.The cause of the discordant prothrombin time (pt) and prothrombin time international normalized ratio (inr) results cannot be determined.The use of bd 1.8 ml blood collection tube, as well as pre-analytical issues during collection such as incomplete sample mixing immediately after blood collection, cannot be ruled out as possible causes.Variances in reagent sensitivity and other interferences also cannot be ruled out.The cause of the discordant, falsely elevated pt and inr results is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00028 was filed for the discordant pt and inr results obtained on (b)(6) 2020.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a sysmex cs-5100 system (serial number: (b)(4)) using dade innovin reagent.The sample had previously been run for pt and inr on an alternate sysmex cs-5100 system (serial number: (b)(4)) using dade innovin reagent which generated a "no coagulation" error and no numeric results.The discordant, falsely elevated pt and inr results were reported to the physician(s) and were questioned.The patient was sent to an alternate hospital to be redrawn and retested for inr.The new sample was run for inr on a non-siemens analyzer, resulting lower.This result was considered correct.The original sample was sent to the alternate hospital and was run for inr on a non-siemens analyzer, resulting lower.This result was also considered correct.The next day, the original sample was retested for pt and inr at the customer's site.The pt and inr both recovered falsely elevated.These discordant results were not reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10148367
• Report Number: 9610806-2020-00027
• Device Sequence Number: 1800768
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR