MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-20

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Architect clinical chemistry carbon dioxide reagent lot number was not provided.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, and labeling review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The architect system operations manual, section 7 (operational precautions and limitations, limitations of result interpretation) states, assay results must be used with other clinical data, for example, symptoms, other test results, patient history, clinical impressions, information available from clinical evaluation, and other diagnostic procedures.All data must be considered for patient care management.If assay results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.The carbon dioxide reagent package insert (interfering substance section) states that interferences from medications or endogenous substances may affect results.Based on all available information and abbott diagnostics complaint investigation, no systematic issue was identified and no product deficiency was found.Literature reference: bowman, christopher, wiencek, joesph, sussman, craig richard, adams, brad, sephel, gregory, colby, jennifer, nichols, james, woodworth, alison, vanderbilt university medical center, nashville, tn, united states pseudometabolic acidosis in patient with severe hypertriglyceridemia endocrine reviews, suppl.Supplement 1 38.3 (jun 2017) (endocrine society meetings, presentation number sat 520, date of presentation april 1, 2017).

Event Description

A literature article included falsely depressed carbon dioxide (co2) results generated using architect clinical chemistry co2 reagents.The following information was included in the article.A (b)(6) male with past medical history of type 2 diabetes mellitus, coronary artery disease (cad), and hypertriglyceridemia presented to the pre-op clinic for routine evaluation prior to carpal tunnel surgery.A basic metabolic panel (reference interval in parentheses) showed a sodium 124 mmol/l (136 to 144), potassium 4.3 mmol/l (3.3 to 4.8), chloride 92 mmol/l (98 to 107), co2 6 mmol/l (23 to 31), and glucose 392 mg/dl (70 to 99).The patient was admitted for diabetic keto-acidosis (dka) and treated with an insulin infusion and iv fluids.Urinalysis was negative for ketones, lactic acid was mildly elevated at 2.6 meq/l, and urine drug screen was negative.The lipid panel (mg/dl) showed triglycerides greater than 5680 (less than 149), hdl 17 (greater than 40), ldl 47 (1 to 129), and cholesterol 814 (0 to 199).Lipase was within the reference interval, however no specific lipase results were provided.Patient denied any nausea, vomiting, or shortness of breath.He was treated with insulin infusion, fenofibrate, fish oil, and rosuvastatin.Review of previous discharge summary for the patient showed a routine office visit with asymptomatic serum co2 less than 5 mmol/l leading to a hospital admission.He was treated for dka over 4 days and metformin was discontinued.Of note, during both admissions, his venous blood gases showed ph 7.39 to 7.43 (7.35 to 7.45) with serum bicarbonate (hco3) 24 to 26 mmol/l (21 to 28).The discordant results between serum basic metabolic panel and blood gas analysis were further investigated.The abstract authors concluded that the pseudometabolic acidosis is due to severe hypertriglyceridemia interference within the spectrophotometric method leading to falsely low co2 concentrations.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6805322
• MDR Text Key: 83070684
• Report Number: 1628664-2017-00319
• Device Sequence Number: 1
• Product Code: KHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03L80-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARCHITECT C16000 ANALYZER; LIST NUMBER 03L77-01; SERIAL NUMBER (B)(4)
• Patient Outcome(s): Other
• Patient Age: 62 YR