On 04/02/2015, an abbott point of care sales support representative was contacted by a customer who reported that i-stat cartridges yielded a discrepant hematocrit/hemoglobin on a (b)(6) female patient.There was no other additional patient information available at the time of this report.Cartridge lot number is unknown at the time of this report.Date: (b)(6) 2015, method: unk, result time: unk, hct: unk, hb: 135, comment: pre-admin testing, patient lost 3 liters of blood; (b)(6) 2015, i-stat, 1608, 0.23, 78, patient received treatment of colloids; (b)(6) 2015, i-stat, 1709, 0.52, 177, sample sent to laboratory for hematocrit testing; (b)(6) 2015, lab, unk, unk, 68, patient was given 3 units of blood based on lab result.Per i-stat1 system manual (art: 714178-00p.Rev.Date 12-feb-14), hematocrit results are affected by the level of total protein as follows: hct increased by ~0.75 %pcv for each increase 1 g/dl tp.At this time there is reason to believe that a malfunction exists based on the information available.An investigation will be initiated when product information (cartridge lot#) becomes available.There are no injuries associated with this event.
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(b)(4).At the time of the initial report there was no lot information available.A search was performed where chem8+ cartridge lot numbers were shipped to abbott (b)(4) between (b)(6)-2015 and (b)(6)-2015 and the following lots were identified (below): lot number: h14355, shipping date: (b)(6)-2015; lot number: h15005, shipping date: (b)(6)-2015; lot number: h15016a, shipping date: (b)(6)-2015; lot number: h15036, shipping date: (b)(6)-2015; lot number: h15053, shipping date: (b)(6)-2015.The investigation was completed on 05/28/2015 for the lots listed above.Retain cartridges were tested and are functioning according to specification.Return product was not available for investigation.On 06/03/2015 new information was received and the customer confirmed that lots h14321 and h15005 were used during the event on (b)(6) 2015.Lot# h14321 was not included in the initial investigation.A revision of the investigation was completed on (b)(6) 2015 which included chem8+ lot# h14321.Retain cartridges were tested and are functioning according to specification.
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