MAUDE Adverse Event Report: EPOCAL INC. EPOC READER; EPOC HOST

Model Number HH-1009-00-00

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens has requested the.Csv files to be sent back for investigation.Limited information was provided with this complaint.Siemens has requested additional information to be provided.

Event Description

The customer reported discrepant hemoglobin results on two patients on the epoc reader when compared to a non-siemens lab analyzer.The customer indicated that patient #2 is deceased and that patient #1 was discharged.Limited information was provided with this complaint.Siemens has requested additional information to be sent.

Manufacturer Narrative

Siemens has completed the investigation: the cause of the hemoglobin (hgb) discrepancy could not be determined from the information provided by the customer.The.Csv files are useful in verifying the sequence of analysis, as well as the other parameters that can be influenced as a result.However, the.Csv files were not helpful in determining the root cause for this event.Epoc calculated hgb is derived from the hematocrit (hct) reading on the epoc device.As per section 12.16.6 of the epoc system manual: "hemoglobin concentration is calculated from the measured hematocrit according to the relation: chgb (g/dl) = hct (decimal fraction) x 34." given this relation, the investigation focused on hct performance of the card lot 01-20215-40.A review of the in-house performance for the card lot 01-20215-40 did not identify any product deficiencies for hct.The failure rate of lot 01-20215-40 is not showing an increased trend in the field, therefore, there is no further evidence that the system or reagent cards are not performing as intended.From the information provided by the customer, there are a few factors that may have contributed to a discrepant hct reading.It is important to note that no repeat tests were performed for the discrepant epoc results.The patients underwent treatment between epoc and laboratory results, and therefore these hgb results cannot be compared directly.Sample handling (collection site, collection method) and testing delays are known to affect test results if proper precautions are not considered.The time between sample collection and analysis for all epoc and laboratory tests is unknown.Additionally, the customer did not know whether the arterial epoc samples were collected near a central line.Sample contamination/dilution can arise when samples are drawn from or near a central line.Increased hemodilution could lead to falsely low hematocrit and hemoglobin results.In addition, the samples were collected with unknown anticoagulant.Following epoc system manual section 12.2.6, samples should be collected exclusively with heparin as the anticoagulant.If no anticoagulant is used, the sample should be tested on epoc within 5 mins of collection.However, it is recommended that all samples are tested immediately.The choice of anticoagulant and time delay can have a significant effect on the epoc hematocrit and hemoglobin results.Based on the complaint and available information, the customer is not alleging that the device caused or contributed to the patient's death.The cause or date of death was not provided by the customer.

• Brand Name: EPOC READER
• Type of Device: EPOC HOST
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• MDR Report Key: 11224249
• MDR Text Key: 258925859
• Report Number: 3002637618-2021-00003
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (y/n): N
• PMA/PMN Number: K113726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HH-1009-00-00
• Device Catalogue Number: 10736398
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1