MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT; ACTIVATED WHOLE BLOOD CLOTTING TIME

Model Number	03P87-25
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
[redacted] cardiac cath lab: [redacted] patient in for diagnostic coronary artery bypass graft angiogram.Given 11,000 units total heparin with act max of 204.Md expressed concern for excessive amount of heparin for case type.Istat.[redacted] cardiac cath lab the istat in or [redacted] (analzyer sn [redacted]) is being questioned on its results today.For patient [redacted], staff ran an act and got a result of 214 which the physicians questioned.The patient received more heparin, and a recheck was performed, and 2 samples were drawn at the same time - one given to cath lab rn and one to perfusion to see if similar results were obtained.Cath lab result was 240 and perfusion got 404 on their machine.Perfusion will help support the next case in or [redacted] as the physicians are not confident in the act values being generated by the istat.Email sent to poct [point of care technician] to review analyzer as there is ongoing questions of heparin issues versus machine issues, and it appears that they are not resolved yet.[redacted] cardiac cath lab: giving heparin doses and not reaching proper anticogulation for pci percutaneous coronary intervention].Act never above 250 despite large amounts of heparin.Istat.[redacted] cardiac cath lab: heparin.Possible delayed or reduced effect of heparin on act.Acts verified on two machines at the same time with resulting act exactly the same.Istat.[redacted] cardiac cath lab: md concerned that heparin used in case was not effective in anti-coagulating patient appropriately.Istat.[redacted] main operating room (or): cath lab istat act (new box, lot #r25349) results 250, while perfusion's act result 321, using anesthesia's heparin supply (brand: sandoz, lot ct02312a).[redacted] cardiac cath lab: it was felt by the attending physician who performed this patient's cardiac catheterization that excess heparin was administered in order to reach a therapeutic act.Act cartridge used: lot r25349 expiration 6/13/26 box 0141.Heparin administration was as follows: 1637 3000 units, 1652 6000 units, 1705 4000 units, act at 1651: 163, act at 1704: 214, act at 1716 240, istat.[redacted] cardiac cath lab: more than expected heparin needed for therapeutic act.Pt weighs [redacted].Initial heparin dose 6000 units @ 1149; act 199 @ 1158; then 4000 units heparin given @ 1159; act 225 @ 1213; then 3000 units of heparin @ 1214; act 296 @ 1227.Dr.[redacted] requested to report heparin.Istat.[redacted] cardiac cath lab: therapeutic heparin dose administered was beyond typical dose for patient weight thereby questioning the effectiveness of the heparin.Istat.[redacted] cardiac cath lab: heparin administration and i-stat act results during pci in cath lab: utilizing istat analyzer sn [redacted] act manufactured 9/2017 was 235 at 1318.Utilizing istat analyzer sn [redacted] act manufactured 5/2009 was 307 at 1326.The same blood sample was utilized for both results.13 minutes later a new sample utilizing 5/2009 istat analyzer was 225.3000 units of heparin was given.17 minutes later act was 261.[redacted] [redacted] s/p [status post] ccl [cardiac cath lab] accessed via rra [ right radial approach].C/b [complicated by] hematoma requiring second tr band placement.[redacted] cardiac cath lab: patient undergoing ra/svc [right atrium/superior vena cava] thrombectomy under general anesthesia in cath lab received a total of 15,000 units of iv heparin with a max intraprocedural act of 240.This case was approximately an hour long.This patient weighed [redacted].Heparin was administered by the anesthesiologist through a single lumen picc [peripherally inserted central catheter] line, which was the only line the team used for medication administration during the procedure.At 1258, the initial dose 7,000-unit dose of heparin was given.The act drawn 5 minutes later was 189.At 1310, an additional 5,000-unit dose was administered.The act drawn 5 minutes after the second dose was 209.At 1322, another 3,000 units of heparin was given.The final act was obtained at 1339, which was 240.Reporter is raising attention to this matter as the team in the room felt that the acts were not accurately reflecting the amount of heparin administered during the procedure.In other words, the team thought the acts would be higher (and had expected the act to be around 250 after the first dose).This could be a possible istat related event or could be related to the act cartridges used during the procedure.Thank you.[redacted] cardiac cath lab: patient received an interventional dose of 6,000 units of heparin by rn in cath lab.The act 7 minutes later read 199.An additional 3,000 units of heparin was given.The act using the istats from room 2 and 3 were 225 and 220 respectively.Every act was well under what would be expected based on the amount of heparin given.This is a possible istat related event.Istat.

• Brand Name: I-STAT
• Common Device Name: ACTIVATED WHOLE BLOOD CLOTTING TIME
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road east; princeton NJ 08540
• MDR Report Key: 24332370
• Report Number: 24332370
• Device Sequence Number: 9754791
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: (01)10054749000156(17)260422(10)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/05/2026
• Report Date (Section F): 02/05/2026

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: Health Professional
• Device Model Number: 03P87-25
• Device Catalogue Number: 03P87-25
• Device Lot Number: R25297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 02/05/2026