MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; EPOC BLOOD ANALYSIS SYSTEM,

Catalog Number	CT-1004-00-00
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed on 19/mar/2018.Retain product was tested and found to be performing to specifications.Return product was not available.Investigation: a review of the device history record confirmed the card lot 02-17273-10 met finished goods release criteria.Ionized calcium and lactate sensor performance with in-house data was acceptable in both blood and aqueous controls.In addition, we reviewed non-conformance reports, quality incident reports, planned deviations, sorting, and complaint records related to the card lot and could not identify any issues pertaining to the customer complaint.No reports of an adverse event were received in this complaint.Based on all information available for the epoc test card lot 02-17273-10, a deficiency has not been identified nor would the issue be likely to cause or contribute to a death or serious injury if it were to recur.Section 12.2.6 of the epoc user manual specifies for ca++ measurement to use li or na heparin only if <10 iu/ml.In addition section 12.8.7.D of the user manual states "highly heparinized samples will decrease the ica; balanced heparin or low heparin collection tubes/syringes are recommended." as per section 12.11.7 d of the epoc user manual, "after the sample collection, lactate rapidly increases in blood as a result of glycolysis by as much as 20% in 3 min and 70% in 30 min at 25°c." we requested the time delay between sample collection and testing but the customer did not provide this information.As the local alere/abbott technical support team in (b)(4) did not find information to confirm nor deny that if "the malfunction were to recur, would be likely to cause or contribute to a death or severe adverse event", they decided to report the event to the local regulatory entity prior to the investigation completion that was performed by epocal (manufacturer/regulatory representative).
Event or Problem Description
A customer from (b)(6) reported (case (b)(4)) that their ionized calcium results are always less than 1 mmol/l and that their lactate values are high (e.G.40, 65 mg/dl).The customer was using epoc test cards (ct-1004-00-00) lot 02-17273-10 and epoc host (hh-1009-00-00) with s/n (b)(4).No adverse event was reported.Customer confirmed the product was discarded.The initial event stated: "local technical support team verified the collection: the collection of patients with liquid heparin (wets syringe with heparin and empties) and performs collection.Results observed by the customer for the majority of patients, in venous and arterial samples.Comparison with other equipment was not performed and raw data was not available".Additional relevant information such as patient information and results was requested on 20-feb-2018 via complaint update ((b)(4)) in the complaints handling tool, but after performing multiple attempts the local technical support team could not get any additional information from the customer.Although epocal determined on 07-mar-2018 that this complaint does not meet the reportability criteria, the local alere/abbott technical support team in (b)(4) decided to report to the local regulatory entity.The reportable event report was submitted on 16-mar-2018 to the (b)(6) as a "malfunction" (government agency case (b)(4)).Epocal concluded the case investigation on 19-mar-2018 for ionized calcium and lactate sensor performance and did not identify any product deficiencies.The customer issue was not replicated and case was reassigned to the local alere/abbott technical support team for customer follow-up.The case was closed on 26-mar-2018 by epocal without taking into consideration that the event was reported in (b)(6) and thus not submitting a mdr to us fda.This event was flagged for review during an external audit that was performed between 16-jul-2018 and 20-jul-2018.It was identified that because the incident was reported to (b)(6) and the same device is marketed in the united states that the incident should be reported to the fda.This report is intended to correct this oversight.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: EPOC BLOOD ANALYSIS SYSTEM,
• Manufacturer (Section D): EPOCAL INC.; 855 brookfield road; ottawa, ontario K1V 2 S5; CA K1V 2S5
• MDR Report Key: 7723460
• Report Number: 3004959793-2018-00001
• Device Sequence Number: 16512747
• Product Code: KHP
• UDI-Device Identifier: 00809708047283
• UDI-Public: 00809708047283
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/17/2018
• Device Catalogue Number: CT-1004-00-00
• Device Lot Number: 02-17273-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1